BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    MDR report key: 19726365 · Received July 11, 2024

    Report

    Report Number
    3002773840-2024-00363
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 8, 2024
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    PAM
    UDI-DI
    00815381020338
    PMA / PMN Number
    K193519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE PSUEDOMONAS AERUGINOSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING THE PATIENT'S BLOOD CULTURE SAMPLE. 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: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE PATIENT WAS AN 88-YEAR-OLD FEMALE WITH SIGNS AND SYMPTOMS OF SEPSIS AT THE TIME OF TESTING. ON (B)(6) 2024, THE PATIENT'S POSITIVE BLOOD CULTURE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. THE CUSTOMER STATED SAME SAMPLE WAS NOT USED FOR ADDITIONAL TESTING. GRAM-NEGATIVE BACILLI WERE OBSERVED ON GRAM STAIN. ON (B)(6) 2024, P. AERUGINOSA WAS RECOVERED FROM CULTURE. THE PATIENT'S BLOOD CULTURE SAMPLE WAS ALSO RETESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED P. AERUGINOSA AS DETECTED. DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S ANTIBIOTIC TREATMENT WAS DELAYED FOR 24 HOURS. THE PATIENT WAS NOT HARMED DUE TO HIS DELAY AND NO SERIOUS INJURY OR DEATH WAS REPORTED. THE FINAL DIAGNOSIS OF THE PATIENT WAS SEPSIS. IN-HOUSE INVESTIGATION: FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER # (B)(6)) THAT WAS USED FOR THE BIOFIRE BCID2 PANEL TEST WAS BROUGHT BACK FOR A WORK ORDER TO MAKE SURE THAT THE INSTRUMENT WAS NOT CONTRIBUTING TO THE FALSE NEGATIVE RESULT OBSERVED AT THE CUSTOMER SITE. UPON COMPLETION OF THE WORK ORDER, THERE WAS NO EVIDENCE TO SUGGEST THAT THE FALSE NEGATIVE RESULT WAS CAUSED BY THE FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER # (B)(6)). CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE P. AERUGINOSA RESULT WAS DUE TO A BIOFIRE BCID2 PANEL POUCH ANOMALY. BIOFIRE IS CONTINUOUSLY MONITORING THE MANUFACTURING PROCESS AND HAS CONTROLS IN PLACE TO ENSURE PRODUCT IS MANUFACTURED TO THE HIGHEST QUALITY. EACH BIOFIRE REAGENT LOT IS QUALIFIED PRIOR TO PRODUCT RELEASE; THIS QUALIFICATION INCLUDES A HIGH STATISTICAL-CONFIDENCE SAMPLING TO CONFIRM THAT THE KIT COMPONENTS RELEASED FOR CUSTOMER USE ARE CONFORMING. ALL QUALITY CONTROL (QC) METRICS FOR THE POUCH LOT AND INSTRUMENT WERE MET, AND THEY PASSED QC. REVIEW OF THE ASSOCIATED INSTRUMENT SHOWED THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATION AND WERE NOT EXPECTED TO HAVE CONTRIBUTED TO THE DISCREPANCIES OBSERVED BY THE CUSTOMER. OVERALL, THE BIOFIRE BCID2 PANEL P. AERUGINOSA ASSAY HAS A FALSE NEGATIVE RATE OF <0.001 IN THE FIELD OVER THE LAST YEAR. THESE RATES ARE WITHIN BIOFIRE SYSTEM SPECIFICATIONS. CLINICAL PERFORMANCE: ACCORDING TO TABLE 36. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, PSEUDOMONAS AERUGINOSA OF THE BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE (WWW.ONLINE-IFU.COM/ITI0048), THE PERFORMANCE CLAIM FOR THE P. AERUGINOSA ASSAY COMPARED TO STANDARD MANUAL AND AUTOMATED MICROBIOLOGICAL/BIOCHEMICAL IDENTIFICATION METHODS SHOWED AN OVERALL SENSITIVITY OF 96.4% (95% CI 87.7-99.0% AND AN OVERALL SPECIFICITY OF 99.9% (95% CI 99.5-100%). ARCHIVED TESTING WAS NOT PERFORMED FOR P. AERUGINOSA. 16/16 SINGLE SEEDED SPECIMENS WERE TRUE POSITIVES, AND 8/10 SPECIMENS THAT WERE CO-SEEDED WITH E. FAECALIS WERE DETECTED. E. FAECALIS WAS DETECTED IN 10/10 OF THE CO-SEEDED SPECIMENS. P. AERUGINOSA WAS DETECTED IN BOTH FALSE POSITIVE SPECIMENS.

    Description of Event or Problem · 0

    SUMMARY: ((B)(6) REPORTED A POTENTIAL FALSE NEGATIVE PSUEDOMONAS AERUGINOSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING THE PATIENT'S BLOOD CULTURE SAMPLE. 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.

    Description of Event or Problem · 0

    SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE PSUEDOMONAS AERUGINOSA RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING THE PATIENT'S BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL RESULT, THE PATIENT'S ANTIBIOTIC TREATMENT WAS DELAYED. THE PATIENT WAS NOT HARMED DUE TO THIS DELAY AND NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE P. AERUGINOSA RESULT WAS DUE TO A BIOFIRE BCID2 PANEL POUCH ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272092 BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL PAM BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0147 0538724 00815381020338

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female