FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL
Report
- Report Number
- 3002773840-2024-00405
- Event Type
- Injury
- Date Received
- October 9, 2024
- Date of Event
- August 14, 2024
- Report Date
- November 7, 2024
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PLO
- UDI-DI
- 00815381020123
- PMA / PMN Number
- K160462
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: A PATIENT'S CSF SAMPLE WAS COLLECTED VIA LUMBAR PUNCTURE AND TESTED ON THE FILMARRAY ME PANEL ON (B)(6) 2024. THE FILMARRAY ME PANEL REPORTED C. NEOFORMANS/GATTII AS DETECTED. ON (B)(6) 2024, THE CUSTOMER COMMUNICATED THE FOLLOWING: THE CUSTOMER REPORTED THAT DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS ADMINISTERED AMPHOTERICIN B AND THE PATIENT DEVELOPED KIDNEY FAILURE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT PRESENTED WITH RIGHT FACIAL ASYMMETRY, SPEECH FAILURES, AND RIGHT HEMIPARESIS. INITIAL ANTIBIOTIC COVERAGE WAS WITH CEFTRIAXONE AND VANCOMYCIN. THE CUSTOMER REPORTED LEUKOCYTOSIS IMPROVED, HOWEVER, MOTOR AGITATION AND DISORIENTATION WITH EPISODES OF DELIRIUM PERSISTED. THE CUSTOMER ALSO STATED THAT THE PATIENT WAS DIAGNOSED WITH "FEBRILE SYNDROME UNDER STUDY, POSSIBLE NEURO-INFECTION, POORLY CONTROLLED INSULIN-DEPENDENT DIABETES MELLITUS TYPE 2 WITH SEVERE COMPLICATION, KETOACIDOSIS, POORLY CONTROLLED HYPERTENSION, BENIGN PROSTATIC HYPERPLASIA, AND ALTERED CONSCIOUSNESS SYNDROME." THE SIMPLE BRAIN CT SCAN OF THE PATIENT LOOKED NORMAL AND THE FOLLOWING LABORATORY RESULTS WERE PROVIDED: URINE CULTURE: NEGATIVE COMPLETE BLOOD COUNT: LEUKOCYTOSIS FILMARRAY: CRYPTOCOCCUS NEOFORMANS/GATTII DETECTED INDIA INK: NEGATIVE. ANTIGEN BY IMMUNOCHROMATOGRAPHY: NEGATIVE. CULTURE: NEGATIVE. CYTOCHEMISTRY: PROTEIN AND GLUCOSE LEVELS WERE LOW WITHOUT LEUKOCYTES AND RED BLOOD CELLS, SO ANTIBIOTICS WERE WITHDRAWN. ADA: NORMAL. HIV: NEGATIVE. THE CUSTOMER STATED "PRIOR TO THE START OF ANTIFUNGALS, THE PATIENT ALREADY SHOWED IMPROVEMENT IN HIS STATE OF CONSCIOUSNESS. INFECTIOLOGY INDICATED THAT IT COULD BE A FALSE POSITIVE OF THE FILMARRAY, BUT BASED ON THE RISK/BENEFIT, ANTIBIOTIC THERAPY IS CONTINUED. THE CASE WAS REFERRED TO THE PATIENT SAFETY COMMITTEE." ON (B)(6) 2024, THE FOLLOWING RESULTS FOR CSF CYTOCHEMISTRY WERE PROVIDED: CLEAR APPEARANCE, PROTEINS 60 MG/DL (REFERENCE VALUE 15-40), GLUCOSE 140 MG/DL, (REFERENCE VALUE 40-70), AND PH 6.0. ON (B)(6) 2024, WHEN ASKED HOW THE FILMARRAY RESULT AFFECTED THE PATIENT, THE CUSTOMER STATED "THE FILMARRAY RESULT WAS POSITIVE FOR CRYPTOCOCCUS NEOFORMANS/GATTII, SO ANTIBIOTIC TREATMENT WAS DISCONTINUED AND AMPHOTERICIN B DEOXYCHOLATE AND FLUCONAZOLE WERE STARTED. THE INFECTION COMMITTEE SUGGESTED A FALSE POSITIVE RESULT OF THE FILMARRAY BASED ON THE NEGATIVE RESULTS OF THE COMPLEMENTARY TESTS OF INDIA INK, ANTIGEN AND CULTURE." ADDITIONALLY, CUSTOMER COMMUNICATION INDICATED THAT THE PATIENT'S CLINICAL SIGNS/SYMPTOMS AT THE TIME OF TESTING WERE EXPANDED COMPARED TO SEPTEMBER 9 COMMUNICATION AND INCLUDED THE FOLLOWING: "BENIGN PROSTATIC HYPERPLASIA, HYPERTENSIVE CRISIS RESOLVED, DIABETIC KETOACIDOSIS, FEVER, NEUROLOGICAL FOCUS GIVEN BY RIGHT FACIAL SYMMETRY, FAILURES IN LANGUAGE EMISSION, RIGHT HEMIPARESIS, SUSPECTED ACUTE KIDNEY INJURY ON CHRONIC SUBSTRATE TFG 51.62, ANTIBIOTIC COVERAGE WITH CEFTRIAXONE AND VANCOMYCIN, AND PLAINT BRAIN CT SCAN WITHOUT ACUTE LESIONS OR SPACE-OCCUPYING LESIONS." IN THE (B)(6) 2024 COMMUNICATION, SINCE THE CUSTOMER STATED THAT THE PATIENT PRESENTED WITH KIDNEY INJURY AT TIME OF TESTING AND DID NOT CORRELATE THE KIDNEY FAILURE WITH THE FILMARRAY ME PANEL RESULT AS THEY HAD IN PREVIOUS COMMUNICATIONS, BIOFIRE ASKED THE CUSTOMER TO CONFIRM THAT THE PATIENT EXPERIENCED KIDNEY FAILURE DUE TO THE AMPHOTERICIN B TREATMENT. IT WAS ALSO COMMUNICATED THAT TWO CSF SAMPLES WERE COLLECTED THROUGH LUMBAR PUNCTURE ON (B)(6) 2024 AT 11:30 AM AND PLACED IN A STERILE GLASS TUBE. ONE SAMPLE WAS USED ONLY FOR TESTING ON THE ME PANEL, AND THE SECOND SAMPLE WAS USED FOR COMPLEMENTARY TESTS. ON (B)(6) 2024, IT WAS COMMUNICATED THAT, "ALTHOUGH THE PATIENT HAD POORLY CONTROLLED INSULIN-DEPENDENT DIABETES MELLITUS TYPE 2 WITH SEVERE COMPLICATIONS, THE CLIENT'S REPORT IS THAT THE KIDNEY FAILURE WAS CAUSED BY THE TREATMENT WITH AMPHOTERICIN." THE ANALYSIS OF THE FILMARRAY ME PANEL RUN FILE SHOWED A LATE AMPLIFICATION SIGNATURE OF THE C. NEOFORMANS/GATTII ASSAY, SUGGESTING THAT THE TARGET ANALYTE WAS PRESENT AT A LOW LEVEL. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 38LF24 (KIT LOT# 0443324) 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 NUMBER# (B)(6) WAS WORKING WITHIN DESIGNED SPECIFICATIONS. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS CONTAMINATION. CONTAMINATION EVENTS OFTEN PRESENT WITH LATE PCR SIGNATURES AND ARE DIFFICULT TO DISTINGUISH FROM LOW-LEVEL DETECTIONS. ORGANISMS/NUCLEIC ACIDS CAN BE INTRODUCED DURING ANY PART OF THE FILMARRAY ME PANEL TESTING AND POUCH-HANDLING PROCESS. CONTAMINATION CAN ALSO BE INTRODUCED VIA THE LABORATORY ENVIRONMENT, EQUIPMENT SUCH AS PIPETTES, PIPETTE TIPS, ETC., OR PERSONNEL HANDLING THE SAMPLE. THE CUSTOMER REPORTED THAT DECONTAMINATION IS PERFORMED DAILY USING BACTIDINA. BIOFIRE RECOMMENDS DECONTAMINATING BENCH TOPS AND PROCESSING AREAS, POUCH LOADING STATIONS, AND INSTRUMENT EXTERIORS USING 10% BLEACH FOLLOWED BY DEIONIZED WATER (DI) WATER BETWEEN EACH SAMPLE. CHANGING GLOVES FREQUENTLY AND AT LEAST BETWEEN PATIENT SAMPLES, BLEACH WIPES, AND WATER WIPES ARE ALSO RECOMMENDED. BIOFIRE RECOMMENDS REFERRING TO THE "CONTAMINATION PREVENTION & DECONTAMINATION" TECHNICAL NOTE [FLM1-PRT-0230] FOR MORE INFORMATION REGARDING RECOMMENDED DECONTAMINATION AND PREVENTION PRACTICES. IF FALSE POSITIVE RESULTS OCCUR AND CONTAMINATION IS SUSPECTED, BIOFIRE RECOMMENDS CONTINUING PERFORMING ENVIRONMENTAL TESTING/SWABS OF THE AREA WHERE THE FILMARRAY ME PANEL TESTING IS PERFORMED. CAREFUL ADHERENCE TO THE SAMPLE HANDLING AND TESTING PROCEDURES AND PRECAUTIONS DESCRIBED IN THE FILMARRAY ME PANEL INSTRUCTION BOOKLET (WWW.ONLINE-IFU.COM/ITI0035) IS RECOMMENDED TO MINIMIZE THE RISK OF CONTAMINATION THAT COULD LEAD TO ERRONEOUS TEST RESULTS. PRECAUTIONS MAY INCLUDE ADDITIONAL PERSONAL PROTECTIVE EQUIPMENT (PPE), SUCH AS A FACE MASK, WHEN EXPERIENCING SIGNS OR SYMPTOMS OF A RESPIRATORY INFECTION. A BIOSAFETY CABINET USED FOR PERFORMING CSF PATHOGEN TESTING (E.G., CULTURE) SHOULD NOT BE USED FOR SAMPLE PREPARATION OR POUCH LOADING. FILMARRAY ME PANEL IS INDICATED AS AN AID IN THE DIAGNOSIS OF SPECIFIC AGENTS OF MENINGITIS AND/OR ENCEPHALITIS, AND RESULTS ARE MEANT TO BE USED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, AND LABORATORY DATA. RESULTS FROM THE FILMARRAY ME PANEL ARE NOT INTENDED TO BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER PATIENT MANAGEMENT DECISIONS. POSITIVE RESULTS DO NOT RULE OUT CO-INFECTION WITH ORGANISMS NOT INCLUDED IN THE FILMARRAY ME PANEL. THE AGENT DETECTED MAY NOT BE THE DEFINITE CAUSE OF THE DISEASE. NEGATIVE RESULTS DO NOT PRECLUDE CENTRAL NERVOUS SYSTEM (CNS) INFECTION. NOT ALL AGENTS OF CNS INFECTION ARE DETECTED BY THE FILMARRAY ME PANEL, AND SENSITIVITY IN CLINICAL USE MAY DIFFER FROM THAT DESCRIBED IN THE PACKAGE INSERT. FILMARRAY ME PANEL RESULTS MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. NOTE: IT WAS ALSO REPORTED THAT THE PATIENT WAS ON ANTIBIOTIC COVERAGE WITH CEFTRIAXONE AND VANCOMYCIN AT THE TIME OF TESTING. ACCORDING TO THE FILMARRAY ME PANEL INSTRUCTION BOOKLET, ANTIMICROBIAL THERAPY MAY AFFECT (REDUCE) ORGANISM LEVELS IN THE SPECIMEN. ACCORDING TO TABLE 9. FILMARRAY ME PROSPECTIVE CLINICAL PERFORMANCE SUMMARY OF THE FILMARRAY ME PANEL INSTRUCTION BOOKLET, THE PERFORMANCE CLAIM FOR THE C. NEOFORMANS/GATTII ASSAY COMPARED TO PCR WITH BI-DIRECTIONAL SEQUENCING SHOWED AN OVERALL POSITIVE PERCENT AGREEMENT (PPA) OF 100% (1/1) AND AN OVERALL NEGATIVE PERCENT AGREEMENT (NPA) OF 99.7% (95% CI 99.3-99.9%). C. NEOFORMANS/GATTII WAS DETECTED IN 2/4 FALSE POSITIVE (FP) SPECIMENS USING A COMMERCIALLY AVAILABLE ANTIGEN TEST. ONE FP SPECIMEN WAS POSITIVE BY STANDARD CULTURE. TO SUPPLEMENT THE RESULTS OF THE PROSPECTIVE CLINICAL STUDY, AN EVALUATION OF 235 PRESELECTED ARCHIVED SPECIMENS (OF WHICH 25 WERE NEGATIVE) WAS PERFORMED. ACCORDING TO TABLE 14. FILMARRAY ME PANEL ARCHIVED SPECIMEN PERFORMANCE DATA SUMMARY OF THE FILMARRAY ME PANEL INSTRUCTION BOOKLET, THE C. NEOFORMANS/GATTII ASSAY COMPARED TO A CONFIRMATORY MOLECULAR TEST (E.G., PCR WITH BI-DIRECTIONAL SEQUENCING) SHOWED A PPA OF 100% (95% CI 83.2-100%) AND AN NPA OF 100% (95% CI 97.8-100%). ONE SPECIMEN WAS SEQUENCED AND IDENTIFIED AS C. GATTII, AND 18 WERE C. NEOFORMANS.
INVESTIGATION: MIOMED S.A.S REPORTED A POTENTIAL FALSE POSITIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT AFTER TESTING A PATIENT'S CEREBROSPINAL FLUID (CSF) SAMPLE FROM A 67-YEAR-OLD MALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS TREATED WITH AMPHOTERICIN B, WHICH MAY HAVE LED TO PATIENT KIDNEY FAILURE. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. 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.
SUMMARY: MIOMED S.A.S REPORTED A POTENTIAL FALSE POSITIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT AFTER TESTING A CEREBROSPINAL FLUID (CSF) SAMPLE FROM A 67-YEAR-OLD MALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS TREATED WITH AMPHOTERICIN B, WHICH MAY HAVE LED TO PATIENT KIDNEY FAILURE. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULT WAS CONTAMINATION.
SUMMARY: MIOMED S.A.S REPORTED A POTENTIAL FALSE POSITIVE CRYPTOCOCCUS NEOFORMANS/GATTII RESULT AFTER TESTING A PATIENT'S CEREBROSPINAL FLUID (CSF) SAMPLE FROM A 67-YEAR-OLD MALE PATIENT. DUE TO THE FILMARRAY ME PANEL RESULT, THE PATIENT WAS TREATED WITH AMPHOTERICIN B, WHICH MAY HAVE LED TO PATIENT KIDNEY FAILURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2344144 | FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL | FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL | PLO | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0118 | 0443324 | 00815381020123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Other |