FILMARRAY GASTROINTESTINAL (GI) PANEL
Report
- Report Number
- 3002773840-2025-00064
- Event Type
- Death
- Date Received
- September 17, 2025
- Date of Event
- July 18, 2025
- Report Date
- April 29, 2026
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PCH
- UDI-DI
- 00815381020109
- PMA / PMN Number
- K242367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: THE CUSTOMER REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. BIOFIRE MEDICAL AFFAIRS TEAM IS CURRENTLY ASSESSING THIS CASE. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER. A SAMPLE FOR IN-HOUSE TESTING HAS ALSO BEEN REQUESTED. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. CONCLUSION: N/A FOR INITIAL REPORT.
INVESTIGATION: ON (B)(6) 2025 AT 20:29, THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT. PROVIDED PATIENT DETAILS: "THE PATIENT WAS A 12-YEAR-OLD AMISH BOY PRESENTED WITH HISTORY OF 15KG INTENTIONAL WEIGHT LOSS OVER SIX MONTHS AND ACUTE LETHARGY. UPON ADMISSION HIS VITAL SIGNS WERE TEMP: 36.7; HR: 38 BPM, BP: 95/68, AND 99% SATURATION ON ROOM WITH 18 RESPIRATIONS PER MINUTE. ON EXAM HE WAS ENCEPHALOPATHIC, CACHECTIC WITH TEMPORAL WASTING, AND HAD STAGE 1 PRESSURE WOUNDS ON HIS SACRUM. HIS INITIAL LABS REVEALED A WBC COUNT OF 6.6K, HEMOGLOBIN OF 12.4, PLATELETS OF 130K. HIS BMP HAD A CR OF 0.80 WHICH WAS ELEVATED, AST OF 83, A C-REACTIVE PROTEIN OF <0.1 MG/DL, AN ERYTHROCYTE SEDIMENTATION RATE OF 2. HIS PROCALCITONIN WAS NORMAL AT 0.19 MG/ML. HE HAD A NORMAL CHEST RADIOGRAPH. CT OF THE HEAD SHOWED GLOBAL PARENCHYMAL VOLUME LOSS WITH ANASARCA OF THE CRANIAL SOFT TISSUES. ABDOMINAL RADIOGRAPH AND US WERE NORMAL. HE WAS ADMITTED TO THE PEDIATRIC ICU WITH CONCERN FOR ANOREXIA NERVOSA, CHRONIC MALNUTRITION, POSSIBLE SCURVY, SYMPTOMATIC BRADYCARDIA, AND AT HIGH RISK FOR REFEEDING SYNDROME. HE REPORTED NO RECENT OR CHRONIC DIARRHEA." ON (B)(6) 2025 AT 11:31, THE PATIENT WAS TRANSFERRED TO THE GENERAL PEDIATRIC FLOOR. NUTRITION WAS INITIATED AND TOLERATED WELL, INCLUDING NAVY BEANS, ENSURE PLUS, POTATOES. THE PATIENT'S ENCEPHALOPATHY IMPROVED, AND THEY ORIENTED TO PERSON, PLACE, AND TIME. VITAL SIGNS, EXAM, AND ELECTROLYTE WERE MONITORED FREQUENTLY. ON (B)(6) 2025 AT 6:34, THE PATIENT EXPERIENCED WORSENING FATIGUE WITH INABILITY TO STAY AWAKE, FOLLOWED BY SYNCOPAL EPISODE. THE PATIENT'S EXAM SHOWED NEW ECCHYMOSIS AND PETECHIAE OVER KNEES, BACK AND TORSO. THERE WAS NO BLEEDING OF GUMS. THE PATIENT'S HEART RATE INCREASED TO 70'S FROM BRADYCARDIA IN THE 30'S. THE PATIENT'S ELECTROLYTES SHOWED LOW PHOSPHATE, MAGNESIUM, AND POTASSIUM, WHICH WERE REPLACED. AN ECHOCARDIOGRAM + ELECTROCARDIOGRAM (EKG) WERE ORDERED DUE TO CONCERN FOR REFEEDING SYNDROME. INABILITY TO GET IV ACCESS. THE PATIENT WAS RE-ADMITTED BACK TO THE PEDIATRIC ICU AND A CENTRAL LINE PLACED FOR ACCESS. ON (B)(6) 2025 AT 12:56, NON-BLOODY DIARRHEA BEGAN. THE PATIENT BECAME HYPOXIC REQUIRING NASAL CANNULA FOR SUPPLEMENTAL OXYGENATION. THE PATIENT HAD CHEST PAIN WITH EKG SHOWING "T-WAVE INVERSIONS AND QTC OF 542." THE PATIENT'S CHEST X-RAY SHOWED "NEW RIGHT LUNG BASE OPACIFICATION CONSISTENT WITH ASPIRATION VERSUS PNEUMONIA." ON (B)(6) 2025 AT 16:16, A FILMARRAY GI PANEL TEST WAS ORDERED. ON (B)(6) 2025 AT 00:00, DUE TO WORSENING CARDIOPULMONARY SHOCK WITH BRADYCARDIA AND HYPOTENSION EMERGENT EXTRACORPOREAL MEMBRANOUS OXYGENATION (ECMO) BEGAN THROUGH RIGHT NECK APPROACH. THERE WAS CONCERN FOR CARDIOVASCULAR SHOCK SECONDARY TO ANOREXIA, NUTRITIONAL DEFICIENCIES, AND RE-FEEDING. ON (B)(6) 2025 AT 09:13, THE FILMARRAY GI PANEL RESULTS WERE REPORTED. THE FILMARRAY GI PANEL REPORTED ETEC, STEC, AND E. COLI O157 AS DETECTED. THE PATIENT'S CBC SHOWED "NEW LEUKOPENIA WBC: 0.4; HGB: 14.3; PLT: 30; CR: 0.49." ON (B)(6) 2025 AT 11:19, ARTERIAL BLOOD CULTURE WAS SENT. ON (B)(6) 20245 AT 11:24, INFECTIOUS DISEASES (ID) CONSULTED. THERE WAS CONCERN ABOUT POSSIBILITY HEMOLYTIC UREMIC SYNDROME DUE TO FILMARRAY GI PANEL RESULTS. SEPSIS VERSUS CARDIOVASCULAR SHOCK VERSUS COMBINATION WAS CONSIDERED. TREATMENT WAS ADMINISTERED BASED ON GRAM POSITIVE AGENTS ONLY AND HELD GRAM-NEGATIVE RODS (GNR) COVERAGE DUE TO O157 SEEN ON SAMPLE. TREATMENT WITH LINEZOLID WAS STARTED AT 11:40. ON (B)(6) 2025 AT 16:11, THE PATIENT SHOWED PERSISTENT HYPOTENSION AND AN INABILITY TO RESPOND TO PRESSURES. EMPIRIC GNR COVERAGE WITH CEFEPIME WAS INITIATED. ON (B)(6) 2025 AT 20:34, ARTERIAL BLOOD CULTURE GREW E. COLI AT 7.4 HOURS WHICH WAS RESISTANT ONLY TO DOXYCYCLINE. ON (B)(6) 2025 AT 16:57, URINE CULTURE WAS SENT, WHICH ULTIMATELY GREW >100,000 CFU OF E. COLI RESISTANT TO ONLY DOXYCYCLINE. ON (B)(6) 2025 AT 22:19, ENDOTRACHEAL SEPTUM CULTURE WAS SENT, WHICH ULTIMATELY GREW E. COLI ONLY RESISTANT TO DOXYCYCLINE. ON (B)(6), 2025 AT 04:43, CENTRAL LINE BLOOD CULTURE WAS PERFORMED AND THERE WAS NO GROWTH AT 5 DAYS. ON (B)(6) 2025 AT 12:29, THE PATIENT HAD A MULTIORGAN FAILURE, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND REFRACTORY SHOCK. THE PATIENT'S CARE WAS WITHDRAWN, AND THEY WERE REMOVED FROM EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT DIED. TESTING PERFORMED AT WISCONSIN STATE LABORATORY OF HYGIENE (WSLH) ON (B)(6) 2025: ·SHIGA TOXIN-PRODUCING E. COLI WAS NOT OBSERVED. ·SHIGA TOXIN PCR DETECTED EAE GENE, BUT STX1, STX2, AND EXHA GENES WERE NOT DETECTED. PATIENT'S BLOOD CULTURE RECOVERED E. COLI; THE ISOLATE WAS NEGATIVE FOR ANTIGEN AND PCR SHIGA TOXIN. ON (B)(6) 2025, THE SAMPLE WAS RETESTED ON THE FILMARRAY GI PANEL. THE FILMARRAY GI PANEL REPORTED STEC AND E. COLI O157 AS DETECTED (ETEC WAS NOT DETECTED). PLEASE NOTE THAT THE SAMPLE WAS STORED OUTSIDE OF SAMPLE RETENTION RECOMMENDATIONS FOR THIS TEST. THE CUSTOMER REPORTED THAT DUE TO THE DETECTION OF E. COLI O157 ON THE FILMARRAY GI PANEL, THE PATIENT WAS NOT GIVEN ANTIBIOTIC THERAPY AND THE PATIENT PASSED AWAY. THE PATIENT'S CAUSE OF DEATH WAS "E. COLI SEPTICEMIA IN SETTING OF MALNUTRITION/REFEEDING W/ ANOREXIA NERVOSA" AND THEIR FINAL DIAGNOSIS WAS "E. COLI SEPTICEMIA W/ BACTEREMIA, PNEUMONIA, AND BACTERIA IN SETTING OF REFEEDING SYNDROME AND ANOREXIA NERVOSA." THE ANALYSIS OF THE PROVIDED FILMARRAY GI PANEL RUN FILES REVEALED ROBUST SIGNATURES UNDER THE EPEC ASSAY IN BOTH RUNS (WHICH WAS REPORTED AS N/A DUE TO THE DETECTION OF STEC IN BOTH RUNS). THE INITIAL RUN FILE ALSO DISPLAYED LATE SIGNATURES FOR ETEC, STEC, AND E. COLI O157; ALL OF WHICH WERE DETECTED. THE REPEAT RUN FILE DISPLAYED LATE SIGNATURES UNDER THE STEC AND E. COLI O157 ASSAYS, WHILE A FLATLINE SIGNATURE WAS OBSERVED UNDER THE ETEC ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3RMH25 (KIT LOT# 0821825) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE AND THE FILMARRAY INSTRUMENT (SERIAL NUMBERS# (B)(6)) WERE WORKING WITHIN DESIGNED SPECIFICATIONS. BIOFIRE MEDICAL AFFAIRS ASSESSMENT: THE POTENTIAL FALSE POSITIVE RESULT OF O157 STEC INFLUENCED THE DECISION TO WITHHOLD ANTIBIOTIC THERAPY UNTIL BLOOD CULTURE RESULTS REVEALED A GRAM-NEGATIVE BLOODSTREAM INFECTION. ANTIBIOTICS ARE CONTRAINDICATED FOR THE TREATMENT OF STEC INFECTIONS DUE TO THE INCREASED RISK FOR THE DEVELOPMENT OF HEMOLYTIC UREMIC SYNDROME (HUS), PARTICULARLY IN CHILDREN. HOWEVER, IN CERTAIN CASES, INCLUDING PATIENTS WITH SERIOUS COINFECTIONS, THE NEED TO TREAT THE BACTERIAL COINFECTION MAY SUPERSEDE THE MODERATE RISK OF HUS IN PATIENTS WITH STEC. IF CLINICIANS HAD A STRONG SUSPICION OF BACTERIAL PNEUMONIA OR SEPSIS, IT MAY HAVE BEEN APPROPRIATE TO BEGIN EMPIRIC ANTIBIOTIC TREATMENT REGARDLESS OF THE STEC RESULT. AN ALTERNATIVE MOLECULAR METHOD ON THE PRIMARY STOOL SAMPLE SHOULD BE USED TO RESOLVE THE DISCREPANT RESULT BETWEEN STOOL CULTURE & FILMARRAY GI PANEL AS THIS IS WELL KNOWN THAT STOOL CULTURE IS DISPLAYING LOWER SENSITIVITY THAN MOLECULAR DIAGNOSTIC TESTS. ADDITIONALLY, THE RESULTS OF THE FILMARRAY GI PANEL MUST BE INTERPRETED IN THE CONTEXT OF CLINICAL HISTORY AND OTHER DIAGNOSTIC INFORMATION AND SHOULD NOT BE USED AS THE SOLE DETERMINANT OF TREATMENT COURSE. IN PARTICULAR, DUE TO THE PROCLIVITY FOR HORIZONTAL GENE TRANSFER, POSITIVE DETECTION OF MULTIPLE E. COLI PATHOTYPES IN A SAMPLE MAY BE DUE TO TRUE COINFECTION OR TO THE PRESENCE OF A SINGLE ORGANISM WITH GENES CHARACTERISTIC OF MULTIPLE PATHOTYPES. ADDITIONAL TESTING AND/OR CLINICAL EVALUATION MAY BE NECESSARY TO DETERMINE THE TRUE CAUSE OF INFECTION. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE-POSITIVE RESULTS WAS DIFFERENCES IN SENSITIVITY/SPECIFICITY BETWEEN METHODS IN A POLYMICROBIAL SAMPLE WITH ANALYTE CONCENTRATION NEAR THE LIMIT OF DETECTION (LOD) OF THE FILMARRAY GI PANEL. THE DETECTION OF AN ORGANISM OR ITS NUCLEIC ACID AT A LOW CONCENTRATION IN THE SAMPLE CAN VARY FROM POUCH TO POUCH, AND AN ANALYTE NEAR THE LOD OF THE FILMARRAY GI PANEL MAY NOT ALWAYS BE DETECTED UPON RETESTING. LOD INFORMATION CAN BE FOUND IN TABLE 22. LIMIT OF DETECTION (LOD) FOR BIOFIRE GI PANEL ANALYTES OF THE FILMARRAY GI PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0030). THE CUSTOMER NOTED THAT THEY HAD STORED THE SAMPLE IMPROPERLY PRIOR TO PERFORMING THE REPEAT FILMARRAY GI PANEL TEST, WHICH CAN ADVERSELY IMPACT THE ACCURACY OF RESULTS. THE WSLH REFERENCE LAB DID IDENTIFY THE EAE GENE IN THE STOOL SAMPLE, WHICH IS CONSISTENT WITH THE ROBUST EPEC SIGNATURES IN BOTH FILMARRAY GI PANEL RUNS. "SHIGA TOXIN NEGATIVE" E. COLI WAS IDENTIFIED VIA BLOOD CULTURE, AND E. COLI WAS IDENTIFIED IN CULTURES OF URINE AND SPUTUM. THE CUSTOMER STATED THAT WSLH DID NOT IDENTIFY E. COLI O157 IN "STOOLS, RESPIRATORY ISOLATE, OR BLOOD ISOLATE." THE RUN FILES INDICATE THAT ETEC AND STEC, WITH E. COLI O157, MAY HAVE BEEN PRESENT IN THE PATIENT'S SAMPLE AT A VERY LOW LEVEL, LEADING TO AN INABILITY TO CONFIRM VIA PHENOTYPIC TESTING AND OTHER MOLECULAR METHODS. ACCORDING TO THE FILMARRAY GI PANEL INSTRUCTION BOOKLET, THE FILMARRAY GI PANEL DETECTS EPEC THROUGH TARGETING OF THE EAE GENE, WHICH ENCODES THE ADHESIN INTIMIN. AS SOME STEC ALSO CARRY EAE, THE FILMARRAY GI PANEL CANNOT DISTINGUISH BETWEEN STEC CONTAINING EAE AND A CO-INFECTION OF EPEC AND STEC. THEREFORE, THE EPEC RESULT IS NOT APPLICABLE (N/A) AND NOT REPORTED FOR SPECIMENS IN WHICH STEC HAS ALSO BEEN DETECTED. THE FILMARRAY GI PANEL IS A QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED IN VITRO DIAGNOSTIC TEST CAPABLE OF THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF NUCLEIC ACIDS FROM MULTIPLE BACTERIA, VIRUSES, AND PARASITES DIRECTLY FROM STOOL SAMPLES IN CARY BLAIR TRANSPORT MEDIA OBTAINED FROM INDIVIDUALS WITH SIGNS AND/OR SYMPTOMS OF GASTROINTESTINAL INFECTION. BACTERIAL, VIRAL, AND PARASITE NUCLEIC ACIDS CAN PERSIST IN VIVO INDEPENDENTLY OF ORGANISM VIABILITY, AND THE DETECTION OF ORGANISM TARGETS DOES NOT GUARANTEE THAT THE CORRESPONDING ORGANISMS ARE INFECTIOUS OR THE CAUSATIVE AGENTS FOR CLINICAL SYMPTOMS. WHILE RARE, DISCREPANCIES BETWEEN FILMARRAY GI PANEL AND OTHER METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT OBSERVED IN THE FIELD. THE DETECTION OF BACTERIAL, VIRAL, AND PARASITIC NUCLEIC ACIDS IS DEPENDENT UPON PROPER SAMPLE COLLECTION, HANDLING, TRANSPORTATION, STORAGE, AND PREPARATION. FAILURE TO OBSERVE PROPER PROCEDURES IN ANY ONE OF THESE STEPS CAN LEAD TO INCORRECT RESULTS. DETECTION OF ORGANISM TARGETS DOES NOT IMPLY THAT THE CORRESPONDING ORGANISMS ARE INFECTIOUS OR ARE THE CAUSATIVE AGENTS FOR CLINICAL SYMPTOMS. RESULTS FROM THE FILMARRAY GI PANEL TEST MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. THERE IS A RISK OF FALSE POSITIVE VALUES RESULTING FROM CROSS-CONTAMINATION BY TARGET ORGANISMS, THEIR NUCLEIC ACIDS OR AMPLIFIED PRODUCT, OR FROM NON-SPECIFIC SIGNALS IN THE ASSAY. STATE AND LOCAL PUBLIC HEALTH AUTHORITIES HAVE PUBLISHED GUIDELINES FOR NOTIFICATION OF REPORTABLE DISEASES IN THEIR JURISDICTIONS, INCLUDING SALMONELLA, SHIGELLA, V. CHOLERAE, E. COLI O157, ETEC, AND STEC TO DETERMINE NECESSARY MEASURES FOR VERIFICATION OF RESULTS TO IDENTIFY AND TRACE OUTBREAKS. LABORATORIES ARE RESPONSIBLE FOR FOLLOWING THEIR STATE OR LOCAL REGULATIONS FOR SUBMISSION OF CLINICAL MATERIAL OR ISOLATES ON POSITIVE SPECIMENS TO THEIR STATE PUBLIC HEALTH LABORATORIES. NOTE: THE CUSTOMER MENTIONED CLEANING THE BSC WHERE THE FILMARRAY GI PANEL POUCHES ARE LOADED TWICE A DAY WITH 10% BLEACH (PREPARED DAILY), FOLLOWED BY 70% ETHANOL AS PART OF THEIR OVERALL DECONTAMINATION PROCESS. THIS ASPECT OF THE CUSTOMER'S DECONTAMINATION PROCESS MAY NOT BE ADEQUATE TO CONTROL FOR NUCLEIC ACID CONTAMINATION OF THE WORKING AREA. BIOFIRE RECOMMENDS CLEANING THE BSC WITH AN APPROPRIATE REAGENT (SUCH AS THE CUSTOMER'S USE OF FRESHLY PREPARED 10% BLEACH FOLLOWED BY 70% ETHANOL) BETWEEN EACH SPECIMEN. ADDITIONALLY, IF FALSE POSITIVE RESULTS OCCUR AND CONTAMINATION IS SUSPECTED, BIOFIRE RECOMMENDS PERFORMING ENVIRONMENTAL TESTING/SWABS OF THE AREA WHERE FILMARRAY GI PANEL TESTING IS PERFORMED. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 12 AND 20 OF THE FILMARRAY GI PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0030).
INVESTIGATION: ON (B)(6) 2025 AT 20:29, THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT. PROVIDED PATIENT DETAILS: "THE PATIENT WAS A 12-YEAR-OLD AMISH BOY PRESENTED WITH HISTORY OF 15KG INTENTIONAL WEIGHT LOSS OVER SIX MONTHS AND ACUTE LETHARGY. UPON ADMISSION HIS VITAL SIGNS WERE TEMP: 36.7; HR: 38 BPM, BP: 95/68, AND 99% SATURATION ON ROOM WITH 18 RESPIRATIONS PER MINUTE. ON EXAM HE WAS ENCEPHALOPATHIC, CACHECTIC WITH TEMPORAL WASTING, AND HAD STAGE 1 PRESSURE WOUNDS ON HIS SACRUM. HIS INITIAL LABS REVEALED A WBC COUNT OF 6.6K, HEMOGLOBIN OF 12.4, PLATELETS OF 130K. HIS BMP HAD A CR OF 0.80 WHICH WAS ELEVATED, AST OF 83, A C-REACTIVE PROTEIN OF <0.1 MG/DL, AN ERYTHROCYTE SEDIMENTATION RATE OF 2. HIS PROCALCITONIN WAS NORMAL AT 0.19 MG/ML. HE HAD A NORMAL CHEST RADIOGRAPH. CT OF THE HEAD SHOWED GLOBAL PARENCHYMAL VOLUME LOSS WITH ANASARCA OF THE CRANIAL SOFT TISSUES. ABDOMINAL RADIOGRAPH AND US WERE NORMAL. HE WAS ADMITTED TO THE PEDIATRIC ICU WITH CONCERN FOR ANOREXIA NERVOSA, CHRONIC MALNUTRITION, POSSIBLE SCURVY, SYMPTOMATIC BRADYCARDIA, AND AT HIGH RISK FOR REFEEDING SYNDROME. HE REPORTED NO RECENT OR CHRONIC DIARRHEA." ON (B)(6) 2025 AT 11:31, THE PATIENT WAS TRANSFERRED TO THE GENERAL PEDIATRIC FLOOR. NUTRITION WAS INITIATED AND TOLERATED WELL, INCLUDING NAVY BEANS, ENSURE PLUS, POTATOES. THE PATIENT'S ENCEPHALOPATHY IMPROVED, AND THEY ORIENTED TO PERSON, PLACE, AND TIME. VITAL SIGNS, EXAM, AND ELECTROLYTE WERE MONITORED FREQUENTLY. ON (B)(6) 2025 AT 6:34, THE PATIENT EXPERIENCED WORSENING FATIGUE WITH INABILITY TO STAY AWAKE, FOLLOWED BY SYNCOPAL EPISODE. THE PATIENT'S EXAM SHOWED NEW ECCHYMOSIS AND PETECHIAE OVER KNEES, BACK AND TORSO. THERE WAS NO BLEEDING OF GUMS. THE PATIENT'S HEART RATE INCREASED TO 70'S FROM BRADYCARDIA IN THE 30'S. THE PATIENT'S ELECTROLYTES SHOWED LOW PHOSPHATE, MAGNESIUM, AND POTASSIUM, WHICH WERE REPLACED. AN ECHOCARDIOGRAM + ELECTROCARDIOGRAM (EKG) WERE ORDERED DUE TO CONCERN FOR REFEEDING SYNDROME. INABILITY TO GET IV ACCESS. THE PATIENT WAS RE-ADMITTED BACK TO THE PEDIATRIC ICU AND A CENTRAL LINE PLACED FOR ACCESS. ON (B)(6) 2025 AT 12:56, NON-BLOODY DIARRHEA BEGAN. THE PATIENT BECAME HYPOXIC REQUIRING NASAL CANNULA FOR SUPPLEMENTAL OXYGENATION. THE PATIENT HAD CHEST PAIN WITH EKG SHOWING "T-WAVE INVERSIONS AND QTC OF 542." THE PATIENT'S CHEST X-RAY SHOWED "NEW RIGHT LUNG BASE OPACIFICATION CONSISTENT WITH ASPIRATION VERSUS PNEUMONIA." ON (B)(6) 2025 AT 16:16, A FILMARRAY GI PANEL TEST WAS ORDERED. ON (B)(6) 2025 AT 00:00, DUE TO WORSENING CARDIOPULMONARY SHOCK WITH BRADYCARDIA AND HYPOTENSION EMERGENT EXTRACORPOREAL MEMBRANOUS OXYGENATION (ECMO) BEGAN THROUGH RIGHT NECK APPROACH. THERE WAS CONCERN FOR CARDIOVASCULAR SHOCK SECONDARY TO ANOREXIA, NUTRITIONAL DEFICIENCIES, AND RE-FEEDING. ON (B)(6) 2025 AT 09:13, THE FILMARRAY GI PANEL RESULTS WERE REPORTED. THE FILMARRAY GI PANEL REPORTED ETEC, STEC, AND E. COLI O157 AS DETECTED. THE PATIENT'S CBC SHOWED "NEW LEUKOPENIA WBC: 0.4; HGB: 14.3; PLT: 30; CR: 0.49." ON (B)(6) 2025 AT 11:19, ARTERIAL BLOOD CULTURE WAS SENT. ON (B)(6) 2025 AT 11:24, INFECTIOUS DISEASES (ID) CONSULTED. THERE WAS CONCERN ABOUT POSSIBILITY HEMOLYTIC UREMIC SYNDROME DUE TO FILMARRAY GI PANEL RESULTS. SEPSIS VERSUS CARDIOVASCULAR SHOCK VERSUS COMBINATION WAS CONSIDERED. TREATMENT WAS ADMINISTERED BASED ON GRAM POSITIVE AGENTS ONLY AND HELD GRAM-NEGATIVE RODS (GNR) COVERAGE DUE TO O157 SEEN ON SAMPLE. TREATMENT WITH LINEZOLID WAS STARTED AT 11:40. ON (B)(6) 2025 AT 16:11, THE PATIENT SHOWED PERSISTENT HYPOTENSION AND AN INABILITY TO RESPOND TO PRESSURES. EMPIRIC GNR COVERAGE WITH CEFEPIME WAS INITIATED. ON (B)(6), 2025 AT 20:34, ARTERIAL BLOOD CULTURE GREW E. COLI AT 7.4 HOURS WHICH WAS RESISTANT ONLY TO DOXYCYCLINE. ON (B)(6) 2025 AT 16:57, URINE CULTURE WAS SENT, WHICH ULTIMATELY GREW >100,000 CFU OF E. COLI RESISTANT TO ONLY DOXYCYCLINE. ON (B)(6) 2025 AT 22:19, ENDOTRACHEAL SEPTUM CULTURE WAS SENT, WHICH ULTIMATELY GREW E. COLI ONLY RESISTANT TO DOXYCYCLINE. ON (B)(6) 2025 AT 04:43, CENTRAL LINE BLOOD CULTURE WAS PERFORMED AND THERE WAS NO GROWTH AT 5 DAYS. ON (B)(6) 2025 AT 12:29, THE PATIENT HAD A MULTIORGAN FAILURE, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND REFRACTORY SHOCK. THE PATIENT'S CARE WAS WITHDRAWN, AND THEY WERE REMOVED FROM EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT DIED. TESTING PERFORMED AT (B)(6) LABORATORY OF HYGIENE (WSLH) ON (B)(6) 2025: ·SHIGA TOXIN-PRODUCING E. COLI WAS NOT OBSERVED. ·SHIGA TOXIN PCR DETECTED EAE GENE, BUT STX1, STX2, AND EXHA GENES WERE NOT DETECTED. PATIENT'S BLOOD CULTURE RECOVERED E. COLI; THE ISOLATE WAS NEGATIVE FOR ANTIGEN AND PCR SHIGA TOXIN. ON (B)(6) 2025, THE SAMPLE WAS RETESTED ON THE FILMARRAY GI PANEL. THE FILMARRAY GI PANEL REPORTED STEC AND E. COLI O157 AS DETECTED (ETEC WAS NOT DETECTED). PLEASE NOTE THAT THE SAMPLE WAS STORED OUTSIDE OF SAMPLE RETENTION RECOMMENDATIONS FOR THIS TEST. THE CUSTOMER REPORTED THAT DUE TO THE DETECTION OF E. COLI 0157 ON THE FILMARRAY GI PANEL, THE PATIENT WAS NOT GIVEN ANTIBIOTIC THERAPY AND THE PATIENT PASSED AWAY. THE PATIENT'S CAUSE OF DEATH WAS "E. COLI SEPTICEMIA IN SETTING OF MALNUTRITION/REFEEDING W/ ANOREXIA NERVOSA" AND THEIR FINAL DIAGNOSIS WAS "E. COLI SEPTICEMIA W/ BACTEREMIA, PNEUMONIA, AND BACTERIA IN SETTING OF REFEEDING SYNDROME AND ANOREXIA NERVOSA." THE ANALYSIS OF THE PROVIDED FILMARRAY GI PANEL RUN FILES REVEALED ROBUST SIGNATURES UNDER THE EPEC ASSAY IN BOTH RUNS (WHICH WAS REPORTED AS N/A DUE TO THE DETECTION OF STEC IN BOTH RUNS). THE INITIAL RUN FILE ALSO DISPLAYED LATE SIGNATURES FOR ETEC, STEC, AND E. COLI O157; ALL OF WHICH WERE DETECTED. THE REPEAT RUN FILE DISPLAYED LATE SIGNATURES UNDER THE STEC AND E. COLI O157 ASSAYS, WHILE A FLATLINE SIGNATURE WAS OBSERVED UNDER THE ETEC ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3RMH25 (KIT LOT# 0821825) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE AND THE FILMARRAY INSTRUMENT (SERIAL NUMBERS# (B)(6)) WERE WORKING WITHIN DESIGNED SPECIFICATIONS. BIOFIRE MEDICAL AFFAIRS ASSESSMENT: THE POTENTIAL FALSE POSITIVE RESULT OF O157 STEC INFLUENCED THE DECISION TO WITHHOLD ANTIBIOTIC THERAPY UNTIL BLOOD CULTURE RESULTS REVEALED A GRAM-NEGATIVE BLOODSTREAM INFECTION. ANTIBIOTICS ARE CONTRAINDICATED FOR THE TREATMENT OF STEC INFECTIONS DUE TO THE INCREASED RISK FOR THE DEVELOPMENT OF HEMOLYTIC UREMIC SYNDROME (HUS), PARTICULARLY IN CHILDREN. HOWEVER, IN CERTAIN CASES, INCLUDING PATIENTS WITH SERIOUS COINFECTIONS, THE NEED TO TREAT THE BACTERIAL COINFECTION MAY SUPERSEDE THE MODERATE RISK OF HUS IN PATIENTS WITH STEC. IF CLINICIANS HAD A STRONG SUSPICION OF BACTERIAL PNEUMONIA OR SEPSIS, IT MAY HAVE BEEN APPROPRIATE TO BEGIN EMPIRIC ANTIBIOTIC TREATMENT REGARDLESS OF THE STEC RESULT. AN ALTERNATIVE MOLECULAR METHOD ON THE PRIMARY STOOL SAMPLE SHOULD BE USED TO RESOLVE THE DISCREPANT RESULT BETWEEN STOOL CULTURE & FILMARRAY GI PANEL AS THIS IS WELL KNOWN THAT STOOL CULTURE IS DISPLAYING LOWER SENSITIVITY THAN MOLECULAR DIAGNOSTIC TESTS. ADDITIONALLY, THE RESULTS OF THE FILMARRAY GI PANEL MUST BE INTERPRETED IN THE CONTEXT OF CLINICAL HISTORY AND OTHER DIAGNOSTIC INFORMATION AND SHOULD NOT BE USED AS THE SOLE DETERMINANT OF TREATMENT COURSE. IN PARTICULAR, DUE TO THE PROCLIVITY FOR HORIZONTAL GENE TRANSFER, POSITIVE DETECTION OF MULTIPLE E. COLI PATHOTYPES IN A SAMPLE MAY BE DUE TO TRUE COINFECTION OR TO THE PRESENCE OF A SINGLE ORGANISM WITH GENES CHARACTERISTIC OF MULTIPLE PATHOTYPES. ADDITIONAL TESTING AND/OR CLINICAL EVALUATION MAY BE NECESSARY TO DETERMINE THE TRUE CAUSE OF INFECTION. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE-POSITIVE RESULTS WAS DIFFERENCES IN SENSITIVITY/SPECIFICITY BETWEEN METHODS IN A POLYMICROBIAL SAMPLE WITH ANALYTE CONCENTRATION NEAR THE LIMIT OF DETECTION (LOD) OF THE FILMARRAY GI PANEL. THE DETECTION OF AN ORGANISM OR ITS NUCLEIC ACID AT A LOW CONCENTRATION IN THE SAMPLE CAN VARY FROM POUCH TO POUCH, AND AN ANALYTE NEAR THE LOD OF THE FILMARRAY GI PANEL MAY NOT ALWAYS BE DETECTED UPON RETESTING. LOD INFORMATION CAN BE FOUND IN TABLE 22. LIMIT OF DETECTION (LOD) FOR BIOFIRE GI PANEL ANALYTES OF THE FILMARRAY GI PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0030). THE CUSTOMER NOTED THAT THEY HAD STORED THE SAMPLE IMPROPERLY PRIOR TO PERFORMING THE REPEAT FILMARRAY GI PANEL TEST, WHICH CAN ADVERSELY IMPACT THE ACCURACY OF RESULTS. THE WSLH REFERENCE LAB DID IDENTIFY THE EAE GENE IN THE STOOL SAMPLE, WHICH IS CONSISTENT WITH THE ROBUST EPEC SIGNATURES IN BOTH FILMARRAY GI PANEL RUNS. "SHIGA TOXIN NEGATIVE" E. COLI WAS IDENTIFIED VIA BLOOD CULTURE, AND E. COLI WAS IDENTIFIED IN CULTURES OF URINE AND SPUTUM. THE CUSTOMER STATED THAT WSLH DID NOT IDENTIFY E. COLI O157 IN "STOOLS, RESPIRATORY ISOLATE, OR BLOOD ISOLATE." THE RUN FILES INDICATE THAT ETEC AND STEC, WITH E. COLI O157, MAY HAVE BEEN PRESENT IN THE PATIENT'S SAMPLE AT A VERY LOW LEVEL, LEADING TO AN INABILITY TO CONFIRM VIA PHENOTYPIC TESTING AND OTHER MOLECULAR METHODS. ACCORDING TO THE FILMARRAY GI PANEL INSTRUCTION BOOKLET, THE FILMARRAY GI PANEL DETECTS EPEC THROUGH TARGETING OF THE EAE GENE, WHICH ENCODES THE ADHESIN INTIMIN. AS SOME STEC ALSO CARRY EAE, THE FILMARRAY GI PANEL CANNOT DISTINGUISH BETWEEN STEC CONTAINING EAE AND A CO-INFECTION OF EPEC AND STEC. THEREFORE, THE EPEC RESULT IS NOT APPLICABLE (N/A) AND NOT REPORTED FOR SPECIMENS IN WHICH STEC HAS ALSO BEEN DETECTED. THE FILMARRAY GI PANEL IS A QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED IN VITRO DIAGNOSTIC TEST CAPABLE OF THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF NUCLEIC ACIDS FROM MULTIPLE BACTERIA, VIRUSES, AND PARASITES DIRECTLY FROM STOOL SAMPLES IN CARY BLAIR TRANSPORT MEDIA OBTAINED FROM INDIVIDUALS WITH SIGNS AND/OR SYMPTOMS OF GASTROINTESTINAL INFECTION. BACTERIAL, VIRAL, AND PARASITE NUCLEIC ACIDS CAN PERSIST IN VIVO INDEPENDENTLY OF ORGANISM VIABILITY, AND THE DETECTION OF ORGANISM TARGETS DOES NOT GUARANTEE THAT THE CORRESPONDING ORGANISMS ARE INFECTIOUS OR THE CAUSATIVE AGENTS FOR CLINICAL SYMPTOMS. WHILE RARE, DISCREPANCIES BETWEEN FILMARRAY GI PANEL AND OTHER METHODS ARE PART OF THE NORMAL PERFORMANCE OF THE PRODUCT OBSERVED IN THE FIELD. THE DETECTION OF BACTERIAL, VIRAL, AND PARASITIC NUCLEIC ACIDS IS DEPENDENT UPON PROPER SAMPLE COLLECTION, HANDLING, TRANSPORTATION, STORAGE, AND PREPARATION. FAILURE TO OBSERVE PROPER PROCEDURES IN ANY ONE OF THESE STEPS CAN LEAD TO INCORRECT RESULTS. DETECTION OF ORGANISM TARGETS DOES NOT IMPLY THAT THE CORRESPONDING ORGANISMS ARE INFECTIOUS OR ARE THE CAUSATIVE AGENTS FOR CLINICAL SYMPTOMS. RESULTS FROM THE FILMARRAY GI PANEL TEST MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. THERE IS A RISK OF FALSE POSITIVE VALUES RESULTING FROM CROSS-CONTAMINATION BY TARGET ORGANISMS, THEIR NUCLEIC ACIDS OR AMPLIFIED PRODUCT, OR FROM NON-SPECIFIC SIGNALS IN THE ASSAY. STATE AND LOCAL PUBLIC HEALTH AUTHORITIES HAVE PUBLISHED GUIDELINES FOR NOTIFICATION OF REPORTABLE DISEASES IN THEIR JURISDICTIONS, INCLUDING SALMONELLA, SHIGELLA, V. CHOLERAE, E. COLI O157, ETEC, AND STEC TO DETERMINE NECESSARY MEASURES FOR VERIFICATION OF RESULTS TO IDENTIFY AND TRACE OUTBREAKS. LABORATORIES ARE RESPONSIBLE FOR FOLLOWING THEIR STATE OR LOCAL REGULATIONS FOR SUBMISSION OF CLINICAL MATERIAL OR ISOLATES ON POSITIVE SPECIMENS TO THEIR STATE PUBLIC HEALTH LABORATORIES. NOTE: THE CUSTOMER MENTIONED CLEANING THE BSC WHERE THE FILMARRAY GI PANEL POUCHES ARE LOADED TWICE A DAY WITH 10% BLEACH (PREPARED DAILY), FOLLOWED BY 70% ETHANOL AS PART OF THEIR OVERALL DECONTAMINATION PROCESS. THIS ASPECT OF THE CUSTOMER'S DECONTAMINATION PROCESS MAY NOT BE ADEQUATE TO CONTROL FOR NUCLEIC ACID CONTAMINATION OF THE WORKING AREA. BIOFIRE RECOMMENDS CLEANING THE BSC WITH AN APPROPRIATE REAGENT (SUCH AS THE CUSTOMER'S USE OF FRESHLY PREPARED 10% BLEACH FOLLOWED BY 70% ETHANOL) BETWEEN EACH SPECIMEN. ADDITIONALLY, IF FALSE POSITIVE RESULTS OCCUR AND CONTAMINATION IS SUSPECTED, BIOFIRE RECOMMENDS PERFORMING ENVIRONMENTAL TESTING/SWABS OF THE AREA WHERE FILMARRAY GI PANEL TESTING IS PERFORMED. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 12 AND 20 OF THE FILMARRAY GI PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0030). SUPPLEMENTAL REPORT (NEW INFORMATION): STOOL SAMPLE IN CARY BLAIR WAS SENT TO BIOFIRE FOR TESTING. THE SAMPLE WAS RUN ON THREE (3) GI PANEL POUCHES TO REPRODUCE CUSTOMER RESULTS. IN ONE GI PANEL TEST, POSITIVES WERE REPORTED FOR EPEC ONLY (WITH ROBUST ACTIVITY). IN THE SAME RUN, E. COLI O157 AMPLIFIED WITH LATE ACTIVITY, AND 3/3 MELTS WERE POSITIVE, BUT DID NOT REPORT DETECTED DUE TO STEC ASSAY NEGATIVITY. IN THE OTHER TWO GI PANEL TESTS, STEC AND E. COLI O157 WERE CALLED POSITIVE WITH LATE ACTIVITY, AS OBSERVED BY THE CUSTOMER. EPEC WAS POSITIVE, EXHIBITING ROBUST ACTIVITY AND POSITIVE MELTS, BUT REPORTED AS NOT DETECTED BY THE BIOFIRE SOFTWARE DUE TO THE STEC POSITIVE. ETEC WAS DETECTED IN ONE REPLICATE WITH LATE ACTIVITY. THE SAMPLE WAS STREAKED ONTO BLOOD AGAR AND INCUBATED FOR 24H AT 37°C. MULTIPLE COLONY TYPES WERE OBSERVED, COLONIES UNDERWENT FURTHER ISOLATION AND CHARACTERIZATION. COLONIES FROM THE BLOOD PLATE WERE USED TO INOCULATE MACCONKEY (MAC), HEKTOEN ENTERIC (HE), AND XYLOSE LYSINE DEOXYCHOLATE (XLD) AGARS, AND ALL UNIQUE MORPHOLOGIES FROM THESE PLATES WERE SUBCULTURED AND TESTED ON VITEK2. THE VITEK2 RESULTS IDENTIFIED SPECIES KLEBSIELLA PNEUMONIAE, ENTEROBACTER CLOACAE, CITROBACTER BRAAKII, AND E. COLI. THIS E. COLI COLONY WAS DETERMINED TO BE NON-O157 VIA VITEK2. SORBITOL-MACCONKEY (SMAC) AGAR SUBCULTURING INDICATED A MAJORITY OF COLONIES WAS OBSERVED TO FERMENT SORBITOL (NON-O157), BUT A FEW SMALL, CLEAR COLONIES WERE OBSERVED AND TESTED ON VITEK MS. VITEK MS IDENTIFIED THESE COLONIES AS AEROMONAS SPP. NOTE: KLEBSIELLA PNEUMONIAE, ENTEROBACTER CLOACAE, CITROBACTER BRAAKII, AND AEROMONAS SPP. ARE NOT TARGETS OF THE GI PANEL. CULTURE WAS UNABLE TO IDENTIFY E. COLI O157. NUCLEIC ACID FROM THE STOOL SAMPLE IN CARY BLAIR WAS EXTRACTED AND THE ELUATE WAS TESTED USING INTERNAL COMPARATOR E. COLI O157 AND STX1/STX2 (STEC) PCR ASSAYS. NO POSITIVES WERE OBSERVED WITH THE COMPARATOR PCR TESTS; HOWEVER, IT SHOULD BE NOTED THAT THESE COMPARATOR PCR ASSAYS HAVE A LIMIT OF DETECTION (LOD) THAT ARE HIGHER THAN THE GI PANEL. AS THE GI PANEL HAS A LOWER LOD, IT MAY BE MORE RELIABLE AT AMPLIFYING AND DETECTING THESE TARGETS WHEN THEY ARE PRESENT AT A VERY LOW CONCENTRATION IN THE CLINICAL SPECIMEN. THEREFORE, AN ALTERNATIVE APPROACH WAS PERFORMED TO VERIFY THAT THE POSITIVES OBTAINED DURING GI PANEL TESTING WERE DUE TO THE PRESENCE OF TARGET NUCLEIC ACID (AND NOT THE RESULT OF NON-SPECIFIC AMPLIFICATION). THE ALTERNATIVE APPROACH RECOVERED AMPLICON FROM THE GI PANEL POUCH FROM POSITIVE WELLS AND SEQUENCED. AMPLICON OF ETEC AND O157 TARGET SEQUENCE WAS PRESENT, BUT STEC COULD NOT BE AMPLIFIED. BOTH THE ETEC AND O157 AMPLICON PRODUCED SEQUENCES MATCHING THE EXPECTED GENE TARGET REGIONS. ROBUST SIGNATURES WERE OBSERVED FOR THE EPEC ASSAY IN ALL GI PANEL TESTS (DESPITE BEING REPORTED AS NOT DETECTED DUE TO STEC POSITIVE), WHICH IS FURTHER CONSISTENT WITH THE WSLH PCR TEST WHICH DETECTED THE EAE GENE BUT DID NOT DETECT STX1 OR STX2 (STEC). THESE RESULTS CONFIRM THAT EPEC WAS PRESENT IN THE PATIENT SAMPLE, AND THE PCR SIGNATURES SUGGEST EPEC WAS LIKELY PRESENT AT A MUCH HIGHER CONCENTRATION THAN THE OTHER TARGETS. THE CUSTOMER'S POSITIVE RESULTS WERE REPLICATED INTERNALLY BY TESTING THE SAMPLE ON THE GI PANEL. AMPLICON PRODUCED BY THE GI PANEL TEST WAS SEQUENCED AND FOUND TO BE THE EXPECTED ETEC AND O157 GENE TARGETS. THESE RESULTS SUGGEST THE ETEC AND O157 DETECTIONS WERE UNLIKELY TO BE FROM NON-SPECIFIC ASSAY SIGNALS. RATHER, THEY ARE CONSISTENT WITH WHAT WOULD BE EXPECTED FROM "TRUE DETECTIONS" BY THE GI PANEL. CONVERSELY, THE INTERNAL INVESTIGATION WAS UNABLE TO CONFIRM THE O157, STEC, OR ETEC WITH CULTURE OR USING INDEPENDENT PCR. THE COMBINATION OF INCONSISTENT GI PANEL POSITIVES FOR O157/STEC/ETEC, DIFFICULTY IN RECOVERING IN CULTURE, NEGATIVE COMPARATOR PCR TESTS, AND GI PANEL AMPLICON SEQUENCING SUGGEST THE NUCLEIC ACID FOR THESE TARGETS WAS LIKELY PRESENT IN THE PATIENT'S SAMPLE, BUT AT A LOW CONCENTRATION NEAR LOD.
SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.
SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE-POSITIVE RESULTS WAS A DIFFERENCE IN SENSITIVITY/SPECIFICITY BETWEEN METHODS IN A POLYMICROBIAL SAMPLE WITH ANALYTE CONCENTRATION NEAR THE LIMIT OF DETECTION (LOD) OF THE FILMARRAY GI PANEL.
SUMMARY: (B)(6) HOSPITAL ((B)(6)) REPORTED A POTENTIAL FALSE POSITIVE ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) LT/ST, SHIGA-LIKE TOXIN-PRODUCING ESCHERICHIA COLI (STEC) STX1/STX2, AND E. COLI O157 RESULTS ON THE FILMARRAY GASTROINTESTINAL (GI) PANEL AFTER TESTING A PATIENT STOOL SAMPLE IN CARY BLAIR TRANSPORT MEDIA. THE CUSTOMER REPORTED ANTIBIOTIC THERAPY WAS NOT GIVEN DUE TO THE POSITIVE E. COLI O157 RESULT AND THE PATIENT PASSED AWAY. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE POTENTIAL FALSE-POSITIVE RESULTS WAS A DIFFERENCE IN SENSITIVITY/SPECIFICITY BETWEEN METHODS IN A POLYMICROBIAL SAMPLE WITH ANALYTE CONCENTRATION NEAR THE LIMIT OF DETECTION (LOD) OF THE FILMARRAY GI PANEL. SUPPLEMENTAL REPORT (NEW INFORMATION): THE CUSTOMER PROVIDED SAMPLES FOR IN-HOUSE TESTING. THIS REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OBTAINED FROM THE IN-HOUSE TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569636 | FILMARRAY GASTROINTESTINAL (GI) PANEL | FILMARRAY GASTROINTESTINAL (GI) PANEL | PCH | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0116 | 0821825 | 00815381020109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Male | Death |