BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
Report
- Report Number
- 3002773840-2025-00017
- Event Type
- Death
- Date Received
- March 21, 2025
- Date of Event
- February 17, 2025
- Report Date
- May 29, 2025
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PAM
- UDI-DI
- 00815381020338
- PMA / PMN Number
- K193519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S TREATMENT WAS IMPACTED, RESULTING IN THEIR DEATH. 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.
INVESTIGATION: THE PATIENT WAS A 9-YEAR-OLD MALE. THE PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF TACHYPNEA AND TACHYCARDIA. THE CUSTOMER REPORTED THERE WAS ALSO CONCERN FOR SEPSIS WITH ELEVATED C-REACTIVE PROTEIN (CRP) WHEN BLOOD CULTURES WERE DRAWN. THE PATIENT WAS ALREADY PAN-CYTOPENIC AND NEUTROPENIC. WHEN ASKED WHAT THE UNDERLYING CAUSE OF THE PATIENT'S IMMUNOCOMPROMISED STATUS (PAN-CYTOPENIC AND NEUTROPENIC) WAS, THE CUSTOMER COMMUNICATED THE FOLLOWING: "MULTIFACTORIAL. THE PATIENT WAS PREVIOUSLY HEATHY BUT PRESENTED WITH [FEBRILE INFECTION-RELATED EPILEPSY SYNDROME] FIRES AND ALSO DEVELOPED PANCYTOPENIA (OF UNKNOWN ETIOLOGY DESPITE HEME/ONC INVOLVEMENT) AND [HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS] HLH DURING THE PATIENT'S PROLONGED COURSE OF ILLNESS. THE PATIENT RECEIVED CYTOKINE DIRECTED THERAPY WITH BOTH IL-6 BLOCKER AND ANAKINRA AS WELL AS HIGH-DOSE STEROIDS FOR FIRES. ALSO RECEIVED IMMUNOSUPPRESSIVE THERAPY FOR HLH." WHEN ASKED IF THE PATIENT WAS DIAGNOSED WITH ANY ORGAN FAILURE AT THE TIME OF TESTING, SUCH AS SEPTIC SHOCK, THE NEED FOR MECHANICAL VENTILATION, OR ANY OTHER FORM OF ORGAN SUPPORT, THE CUSTOMER REPORTED THAT THE PATIENT WAS ALREADY VENTILATED DUE TO NEUROLOGICAL ISSUE AND RENAL FAILURES (UNKNOWN TIME POINT FOR VENTILATION AND RENAL FAILURE) AND THE PATIENT DEVELOPED HEPATIC FAILURE DURING ANTIBIOTIC TREATMENT REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ON (B)(6) 2025, THE PATIENT'S BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED STAPHYLOCOCCUS SPP. AND S. AUREUS AS DETECTED. THE BIOFIRE BCID2 PANEL WAS POSITIVE FOR MECA/C BUT NEGATIVE FOR MREJ, RESULTING IN A NOT DETECTED RESULT FOR 'MECA/C AND MREJ (MRSA).' NOTE THAT THE BIOFIRE BCID2 PANEL WILL ONLY REPORT A DETECTED RESULT FOR 'MECA AND MREJ (MRSA)' IF S. AUREUS, MREJ, AND MECA/C ASSAYS ARE ALL POSITIVE. MICROSCAN SUSCEPTIBILITY TESTING SHOWED OXACILLIN (MIC= >2 UG/ML) RESISTANCE AND WAS CEFOXITIN SCREEN POSITIVE (MIC= >4 UG/ML). THE ABBOTT CLEARVIEW PENICILLIN-BINDING PROTEIN 2A (PBP2A) CULTURE COLONY TEST WAS POSITIVE FOR PBP2A. GRAM STAIN SHOWED GRAM-POSITIVE COCCI IN CLUSTERS. THE CUSTOMER REPORTED ANOTHER BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL AND WAS POSITIVE FOR MSSA. THE RUN FILE INFORMATION FOR THIS TEST WAS NOT PROVIDED. THE CUSTOMER REPORTED DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S ANTIBIOTIC TREATMENT WAS CHANGED TO MSSA DIRECTED THERAPY. THIS INAPPROPRIATE CHANGE IN TREATMENT OCCURRED FOR TWO DAYS. THE CUSTOMER STATED THAT THE FALSE NEGATIVE MRSA RESULT ON THE BIOFIRE BCID2 PANEL "DIRECTLY IMPACTED THE PATIENT'S TREATMENT, RESULTING IN THEIR DEATH." THE CUSTOMER COMMUNICATED THE FOLLOWING REGARDING THE PATIENT'S TREATMENT CHANGE: "WHEN THE PATIENT DETERIORATED, INITIALLY, THE PATIENT WAS ON VANCOMYCIN. HOWEVER, ONCE WE RECEIVED THE RESULT OF [BIOFIRE BCID2 PANEL] INDICATING MSSA, WE SWITCHED TO OXACILLIN FOR DIRECTED THERAPY (AND ADDED CLINDAMYCIN FOR TOXIN MEDIATED DISEASE AS HE ALSO DEVELOPED ERYTHRODERMA) GIVEN THE PATIENT ALSO DEVELOPED AKI (WANTED TO AVOID VANC) AS WELL AS RESPIRATORY FAILURE (DAPTO WAS NOT OPTIMAL). GIVEN PANCYTOPENIA, LINEZOLID WAS NOT HIGH ON CUSTOMER OPTIONS INITIALLY. ONCE CULTURE SHOWED MRSA, CUSTOMER SWITCHED OXACILLIN TO CEFTAROLINE FOR MRSA." THE ANALYSIS OF THE INITIAL BIOFIRE BCID2 PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED ROBUST AMPLIFICATION SIGNATURES FOR BOTH MECA/C AND S. AUREUS ASSAYS, WHILE NO MELT/AMPLIFICATION SIGNATURE WAS SEEN FOR THE MREJ ASSAY. IN-HOUSE INVESTIGATION: BIOFIRE RECEIVED ONE TUBE OF ISOLATE AND TWO TUBES OF BLOOD CULTURE ALIQUOTS FOR TESTING. THE TWO BLOOD CULTURE ALIQUOTS WERE TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL DETECTED S. AUREUS, MECA/C AND MREJ (MRSA) FOR BOTH ALIQUOTS. THE MECA/C AND S. AUREUS ASSAYS EACH HAD ROBUST SIGNATURES, WHILE A LATE SIGNATURE WAS OBSERVED FOR THE MREJ ASSAY. THE PATIENT'S BLOOD CULTURE WAS ALSO TESTED ON AN INTERNAL COMPARATOR PCR ASSAY THAT DIFFERENTIATES BETWEEN MREJA & MREJC. 2/2 REPLICATES CALLED POSITIVE FOR MREJA AND 2/2 REPLICATES CALLED POSITIVE FOR MREJC, EACH WITH A LATE SIGNATURE. ADDITIONALLY, THE ISOLATE WAS TESTED TWICE ON THE BIOFIRE BCID2 PANEL AND S. AUREUS, MECA/C AND MREJ (MRSA) WAS DETECTED BOTH TIMES. AGAIN, THE MECA/C AND S. AUREUS ASSAYS EACH HAD ROBUST SIGNATURES, WHILE A LATE SIGNATURE WAS OBSERVED FOR THE MREJ ASSAY. THE INTERNAL COMPARATOR TESTING FOR THE ISOLATE HAD 3/3 REPLICATES CALLED POSITIVE FOR MREJA AND 2/3 REPLICATES CALLED POSITIVE FOR MREJC, EACH WITH LATE SIGNATURES. GROWTH OF ONE MORPHOLOGY TYPE WAS SEEN FROM CULTURE. ISOLATES WERE TESTED USING VITEK® MS AND VITEK® 2, WITH BOTH PLATFORMS IDENTIFYING THE ORGANISM AS S. AUREUS, VITEK® MS REPORTING A HIGH CONFIDENCE. VITEK® 2 AST CONFIRMED MRSA WITH A CEFOXITIN POSITIVE CALL AND OXACILLIN RESISTANCE. BASED ON THE BIOFIRE BCID2 PANEL'S AMPLIFICATION SIGNATURE PATTERN OF S. AUREUS, MECA/C, AND MREJ ASSAYS, IT IS LIKELY THAT THE PATIENT SAMPLE CONTAINED A MRSA STRAIN CARRYING AN MREJ VARIANT WITH REDUCED REACTIVITY ON THE BIOFIRE BCID2 PANEL. WHOLE GENOME SEQUENCING RESULTS MAY PROVIDE ADDITIONAL SEQUENCE INFORMATION ON THE SPECIFIC MREJ VARIANT. FOR FURTHER INVESTIGATION, THE MRSA ISOLATE WAS ALSO GROWN TO A HIGH TITER IN LIQUID CULTURE IN ORDER TO PREPARE A GLYCEROL STOCK AND WAS SENT OUT FOR WHOLE GENOME SEQUENCING. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3H7D24 (KIT LOT# 1977124) WERE ALSO 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: INVESTIGATION ONGOING.
INVESTIGATION: THE PATIENT WAS A 9-YEAR-OLD MALE. THE PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF TACHYPNEA AND TACHYCARDIA. THE CUSTOMER REPORTED THERE WAS ALSO CONCERN FOR SEPSIS WITH ELEVATED C-REACTIVE PROTEIN (CRP) WHEN BLOOD CULTURES WERE DRAWN. THE PATIENT WAS ALREADY PAN-CYTOPENIC AND NEUTROPENIC. WHEN ASKED WHAT THE UNDERLYING CAUSE OF THE PATIENT'S IMMUNOCOMPROMISED STATUS (PAN-CYTOPENIC AND NEUTROPENIC) WAS, THE CUSTOMER COMMUNICATED THE FOLLOWING: "MULTIFACTORIAL. THE PATIENT WAS PREVIOUSLY HEATHY BUT PRESENTED WITH [FEBRILE INFECTION-RELATED EPILEPSY SYNDROME] FIRES AND ALSO DEVELOPED PANCYTOPENIA (OF UNKNOWN ETIOLOGY DESPITE HEME/ONC INVOLVEMENT) AND [HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS] HLH DURING THE PATIENT'S PROLONGED COURSE OF ILLNESS. THE PATIENT RECEIVED CYTOKINE DIRECTED THERAPY WITH BOTH IL-6 BLOCKER AND ANAKINRA AS WELL AS HIGH-DOSE STEROIDS FOR FIRES. ALSO RECEIVED IMMUNOSUPPRESSIVE THERAPY FOR HLH." WHEN ASKED IF THE PATIENT WAS DIAGNOSED WITH ANY ORGAN FAILURE AT THE TIME OF TESTING, SUCH AS SEPTIC SHOCK, THE NEED FOR MECHANICAL VENTILATION, OR ANY OTHER FORM OF ORGAN SUPPORT, THE CUSTOMER REPORTED THAT THE PATIENT WAS ALREADY VENTILATED DUE TO NEUROLOGICAL ISSUE AND RENAL FAILURES (UNKNOWN TIME POINT FOR VENTILATION AND RENAL FAILURE) AND THE PATIENT DEVELOPED HEPATIC FAILURE DURING ANTIBIOTIC TREATMENT REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ON (B)(6) 2025, THE PATIENT'S BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED STAPHYLOCOCCUS SPP. AND S. AUREUS AS DETECTED. THE BIOFIRE BCID2 PANEL WAS POSITIVE FOR MECA/C BUT NEGATIVE FOR MREJ, RESULTING IN A NOT DETECTED RESULT FOR 'MECA/C AND MREJ (MRSA).' NOTE THAT THE BIOFIRE BCID2 PANEL WILL ONLY REPORT A DETECTED RESULT FOR 'MECA AND MREJ (MRSA)' IF S. AUREUS, MREJ, AND MECA/C ASSAYS ARE ALL POSITIVE. MICROSCAN SUSCEPTIBILITY TESTING SHOWED OXACILLIN (MIC= >2 UG/ML) RESISTANCE AND WAS CEFOXITIN SCREEN POSITIVE (MIC= >4 UG/ML). THE ABBOTT CLEARVIEW PENICILLIN-BINDING PROTEIN 2A (PBP2A) CULTURE COLONY TEST WAS POSITIVE FOR PBP2A. GRAM STAIN SHOWED GRAM-POSITIVE COCCI IN CLUSTERS. THE CUSTOMER REPORTED ANOTHER BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL AND WAS POSITIVE FOR MSSA. THE RUN FILE INFORMATION FOR THIS TEST WAS NOT PROVIDED. THE CUSTOMER REPORTED DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S ANTIBIOTIC TREATMENT WAS CHANGED TO MSSA DIRECTED THERAPY. THIS INAPPROPRIATE CHANGE IN TREATMENT OCCURRED FOR TWO DAYS. THE CUSTOMER STATED THAT THE FALSE NEGATIVE MRSA RESULT ON THE BIOFIRE BCID2 PANEL "DIRECTLY IMPACTED THE PATIENT'S TREATMENT, RESULTING IN THEIR DEATH." THE CUSTOMER COMMUNICATED THE FOLLOWING REGARDING THE PATIENT'S TREATMENT CHANGE: "WHEN THE PATIENT DETERIORATED, INITIALLY, THE PATIENT WAS ON VANCOMYCIN. HOWEVER, ONCE WE RECEIVED THE RESULT OF [BIOFIRE BCID2 PANEL] INDICATING MSSA, WE SWITCHED TO OXACILLIN FOR DIRECTED THERAPY (AND ADDED CLINDAMYCIN FOR TOXIN MEDIATED DISEASE AS HE ALSO DEVELOPED ERYTHRODERMA) GIVEN THE PATIENT ALSO DEVELOPED AKI (WANTED TO AVOID VANC) AS WELL AS RESPIRATORY FAILURE (DAPTO WAS NOT OPTIMAL). GIVEN PANCYTOPENIA, LINEZOLID WAS NOT HIGH ON CUSTOMER OPTIONS INITIALLY. ONCE CULTURE SHOWED MRSA, CUSTOMER SWITCHED OXACILLIN TO CEFTAROLINE FOR MRSA." THE ANALYSIS OF THE INITIAL BIOFIRE BCID2 PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED ROBUST AMPLIFICATION SIGNATURES FOR BOTH MECA/C AND S. AUREUS ASSAYS, WHILE NO MELT/AMPLIFICATION SIGNATURE WAS SEEN FOR THE MREJ ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3H7D24 (KIT LOT# 1977124) WERE ALSO 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. IN-HOUSE INVESTIGATION: BIOFIRE RECEIVED ONE TUBE OF ISOLATE AND TWO TUBES OF BLOOD CULTURE ALIQUOTS FOR TESTING. THE TWO BLOOD CULTURE ALIQUOTS WERE TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL DETECTED S. AUREUS, MECA/C AND MREJ (MRSA) FOR BOTH ALIQUOTS. THE MECA/C AND S. AUREUS ASSAYS EACH HAD ROBUST SIGNATURES, WHILE A LATE SIGNATURE WAS OBSERVED FOR THE MREJ ASSAY. THE ISOLATE WAS TESTED TWICE ON THE BIOFIRE BCID2 PANEL AND S. AUREUS, MECA/C AND MREJ (MRSA) WAS DETECTED BOTH TIMES. AGAIN, THE MECA/C AND S. AUREUS ASSAYS EACH HAD ROBUST SIGNATURES, WHILE A LATE SIGNATURE WAS OBSERVED FOR THE MREJ ASSAY. GROWTH OF ONE MORPHOLOGY TYPE WAS SEEN FROM CULTURE. ISOLATES WERE TESTED USING VITEK® MS AND VITEK® 2, WITH BOTH PLATFORMS IDENTIFYING THE ORGANISM AS S. AUREUS, VITEK® MS REPORTING A HIGH CONFIDENCE. VITEK® 2 AST CONFIRMED MRSA WITH A CEFOXITIN POSITIVE CALL AND OXACILLIN RESISTANCE. BASED ON THE BIOFIRE BCID2 PANEL'S AMPLIFICATION SIGNATURE PATTERN OF S. AUREUS, MECA/C, AND MREJ ASSAYS, INITIAL FINDINGS INDICATED IT WAS LIKELY THAT THE PATIENT SAMPLE CONTAINED A MRSA STRAIN CARRYING AN MREJ VARIANT WITH REDUCED REACTIVITY ON THE BIOFIRE BCID2 PANEL. WHOLE GENOME SEQUENCING WAS PERFORMED TO PROVIDE ADDITIONAL INFORMATION ON THE SPECIFIC MREJ VARIANT. THE MRSA ISOLATE WAS GROWN TO A HIGH TITER IN LIQUID CULTURE TO PREPARE A GLYCEROL STOCK FOR WHOLE GENOME SEQUENCING. ANALYSIS OF TARGET SEQUENCES OBSERVED MULTIPLE MISMATCHES UNDER THE MREJ ASSAY'S PRIMER BINDING SITES. THE ANALYSIS FURTHER INDICATED THE ISOLATE RECOVERED FROM THE PATIENT'S BLOOD CULTURE IS LIKELY AN MREJ VARIANT THAT IS EXPECTED TO EITHER HAVE REDUCED OR NO REACTIVITY (NOT DETECTED) WITH THE BIOFIRE BCID2 PANEL'S MREJ ASSAY. HOWEVER, THE BLOOD CULTURE ALIQUOT AND ISOLATE PROVIDED BY THE CUSTOMER BOTH DETECTED MREJ BY THE BIOFIRE BCID2 PANEL DURING INTERNAL TESTING, SUGGESTING THE MREJ VARIANT CAN BE REPORTED AS DETECTED WHEN THE TARGET NUCLEIC ACID IS PRESENT AT A HIGH CONCENTRATION. ALTERNATIVELY, THE MREJ VARIANT MAY BE REPORTED AS NOT DETECTED WHEN THE TARGET IS NOT PRESENT IN THE BLOOD CULTURE AT HIGH ENOUGH CONCENTRATION, WHICH IS LIKELY THE REASON IT WAS NOT DETECTED AT THE CUSTOMER'S SITE. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT MRSA RESULT WAS DUE TO A MREJ VARIANT THAT HAS REDUCED REACTIVITY WITH THE BIOFIRE BCID2 PANEL'S MREJ ASSAY. THE BIOFIRE BCID2 PANEL IS A MULTIPLEXED NUCLEIC ACID TEST INTENDED FOR THE SIMULTANEOUS QUALITATIVE DETECTION AND IDENTIFICATION OF MULTIPLE BACTERIAL AND YEAST NUCLEIC ACIDS AND SELECT GENETIC DETERMINANTS ASSOCIATED WITH ANTIMICROBIAL RESISTANCE. EACH AMR GENE RESULT IS ASSOCIATED WITH A SINGLE CORRESPONDING ASSAY EXCEPT FOR THE MECA/C AND MREJ RESULT, WHICH IS DEPENDENT ON BOTH THE MECA/C ASSAY AND THE MREJ ASSAY. IN ORDER FOR MECA/C AND MREJ (MRSA) TO BE REPORTED AS DETECTED, THE FILMARRAY MUST BE POSITIVE FOR ALL THREE ASSAYS: S. AUREUS, MECA/C, AND MREJ. MORE INFORMATION ON MECA/C AND MREJ ASSAY INTERPRETATION CAN BE FOUND IN TABLE 10 OF THE BIOFIRE BCID2 PANEL INSTRUCTION FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048). THE ANALYSIS OF THE INITIAL BIOFIRE BCID2 PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED ROBUST AMPLIFICATION SIGNATURES FOR BOTH MECA/C AND S. AUREUS ASSAYS, WHILE NO MELT/AMPLIFICATION SIGNATURE WAS SEEN FOR THE MREJ ASSAY. HOWEVER, THE CUSTOMER'S SUBCULTURE AND SUSCEPTIBILITY TESTING REVEALED MRSA AND GRAM STAIN SHOWED GRAM-POSITIVE COCCI IN CLUSTERS. TO INVESTIGATE FURTHER, IN-HOUSE TESTING AT BIOFIRE WAS PERFORMED, AND THE CUSTOMER'S RESULT OF A NEGATIVE MREJ/NEGATIVE MRSA COULD NOT BE REPRODUCED. ALL BIOFIRE BCID2 PANEL TESTS RAN INTERNALLY WERE POSITIVE RESULTS FOR MECA/C, S. AUREUS, AND MREJ (MRSA). HOWEVER, IT IS NOTEWORTHY THAT THE MREJ SIGNATURES OBSERVED WERE LATER AND LESS ROBUST THAN THOSE SEEN FOR MECA/C AND S. AUREUS. ADDITIONALLY, ANALYSIS OF THE WHOLE GENOME SEQUENCE IDENTIFIED A MREJ VARIANT THAT WOULD BE EXPECTED HAVE REDUCED REACTIVITY WITH THE BIOFIRE BCID2 PANEL'S MREJ ASSAY. ACCORDING TO THE "METHICILLIN RESISTANCE GENES DETECTION BY THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL" TECHNICAL NOTE [BFR0002-4828], METHICILLIN RESISTANCE IN STAPHYLOCOCCUS SPECIES IS PRIMARILY CONFERRED WHEN THE MOBILE SCCMEC GENETIC CASSETTE, CARRYING EITHER OF THE RESISTANCE GENES MECA OR MECC, INTEGRATES INTO A SPECIFIC REGION OF THE STAPHYLOCOCCUS GENOME. IN S. AUREUS, THIS STAPHYLOCOCCAL CASSETTE CHROMOSOME MEC (SCCMEC) INSERTION CREATES A JUNCTION BETWEEN THE S. AUREUS GENOME AND THE SCCMEC CASSETTE THAT IS CALLED MREJ (SCCMEC RIGHT-EXTREMITY JUNCTION). THE BIOFIRE BCID2 PANEL'S MREJ ASSAY IS DESIGNED TO DETECT THIS SPECIFIC INTEGRATION EVENT IN THE S. AUREUS GENOME. THERE ARE A VARIETY OF DIFFERENT MREJ TYPES (I-XXI) CLASSIFIED BY THE POINT OF INSERTION OF SCCMEC INTO S. AUREUS. THE MREJ ASSAY IS PREDICTED TO HAVE IMPAIRED REACTIVITY OR BE NON-REACTIVE TO SOME OF THESE MREJ TYPES AND VARIANT SEQUENCES. THESE MREJ TYPES INCLUDE IX, XV, AND XVIII, AS WELL AS TYPES XIX AND XX (ASSOCIATED WITH METHICILLIN-SENSITIVE S. AUREUS; MSSA), AND MREJ SEQUENCES ANNOTATED FROM NON-AUREUS STAPHYLOCOCCUS SPECIES AND NON-STAPYLOCOCCI ORGANISMS. MORE INFORMATION CAN BE FOUND IN TABLE 118. RESULTS FOR MECA/C AND MREJ(MRSA) IN STAPHYLOCOCCUS AUREUS ISOLATES TESTED AND PREDICTED REACTIVITY FOR MREJ TYPES IN THE BIOFIRE BCID2 PANEL'S IFU. OVERALL, EACH AMR GENE ASSAY ON THE BIOFIRE BCID2 PANEL WAS FOUND TO DETECT THE MAJORITY OF AMR GENE TYPES BASED ON TESTING AND ANALYSIS OF AVAILABLE SEQUENCE DATA. HOWEVER, THE MREJ ASSAY MAY BE AFFECTED BY ORGANISM STRAINS THAT CONTAIN SEQUENCE VARIANTS OR REARRANGEMENTS IN THE GENE TARGETS OF THE ASSAY. THE BCID2 PANEL'S MREJ ASSAY IS DESIGNED TO TARGET THE MOST PREVALENT TYPES OF MREJS, BUT NOT ALL KNOWN TYPES. TYPES KNOWN TO HAVE IMPAIRED OR NO REACTIVITY ARE LISTED IN TABLE 118 OF THE BIOFIRE BCID2 PANEL'S IFU, HOWEVER, THE SPECIFIC MREJ VARIANT RECOVERED FROM THIS PATIENT BLOOD CULTURE WAS UNABLE TO BE DEFINITIVELY LINKED TO THOSE LISTED IN TABLE 118. HOWEVER, BASED ON THE SEQUENCE ALIGNMENT, THIS SEQUENCE IS NOT EXPECTED TO BE DETECTED BY THE MREJ ASSAY ON THE BCID2 PANEL, AND MAY BE A NOVEL MREJ TYPE. NOTE: PER THE "LIMITATIONS" SECTION OF THE BIOFIRE BCID2 PANEL IFU, ANTIMICROBIAL RESISTANCE CAN OCCUR VIA MULTIPLE MECHANISMS. A NOT DETECTED RESULT FOR A GENETIC MARKER OF ANTIMICROBIAL RESISTANCE DOES NOT INDICATE SUSCEPTIBILITY TO ASSOCIATED ANTIMICROBIAL DRUGS OR DRUG CLASSES. CULTURE IS REQUIRED TO OBTAIN ISOLATES FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING, AND BIOFIRE BCID2 PANEL RESULTS SHOULD BE USED IN CONJUNCTION WITH CULTURE RESULTS FOR THE DETERMINATION OF SUSCEPTIBILITY OR RESISTANCE. ALL IDENTIFICATION RESULTS PROVIDED BY THE BIOFIRE BCID2 PANEL ARE INTENDED TO BE INTERPRETED IN CONJUNCTION WITH GRAM STAIN RESULTS. THE BIOFIRE BCID2 PANEL RESULTS MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. CLINICAL PERFORMANCE: CLINICAL PERFORMANCE CAN BE FOUND IN TABLE 65. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, MECA/C AND MREJ (MRSA) AND TABLE 81. MECA/C AND MREJ (MRSA) PERFORMANCE TABLE (AS COMPARED TO PHENOTYPIC AST METHODS FOR METHICILLIN (OXACILLIN/CEFOXITIN) RESISTANCE ON CULTURED ISOLATE(S) FROM PROSPECTIVE PBC SPECIMENS) OF THE BIOFIRE BCID2 PANEL IFU (WWW.ONLINE-IFU.COM/ITI0048).
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S TREATMENT WAS IMPACTED, RESULTING IN THEIR DEATH. 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) REPORTED A POTENTIAL NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S TREATMENT WAS IMPACTED, CONTRIBUTING TO THEIR DEATH. BIOFIRE 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) HEALTHCARE REPORTED A POTENTIAL NEGATIVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT'S BLOOD CULTURE SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S TREATMENT WAS IMPACTED, CONTRIBUTING TO THEIR DEATH. UPON INVESTIGATION, NO MALFUNCTION OCCURRED, AND THE BIOFIRE BCID2 PANEL WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DISCREPANT MRSA WAS DUE TO AN ORGANISM STRAIN THAT HAS REDUCED REACTIVITY WITH THE BIOFIRE BCID2 PANEL'S MREJ ASSAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1233520 | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | PAM | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0147 | 1977124 | 00815381020338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Male | Death |