BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11758276 · Received April 30, 2021

    Report

    Report Number
    1119779-2021-00754
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 1012622 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOT 1012622 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED TWO DISCREPANT PATIENT SAMPLES WITH BD MAX SARS-COV-2 REAGENTS KIT LOT 1012622. BOTH PATIENTS OBTAINED AN INITIAL NEGATIVE RESULT WITH AN ANTIGEN TEST WHILE THE BD MAX SARS-COV-2 RESULTS WERE POSITIVE. BOTH PATIENTS DIED AND POST-MORTEM ANALYSIS OF LUNG CELLS, DONE ON A DIFFERENT PCR ANALYZER, WAS NEGATIVE. CUSTOMER PROVIDED TWO RUN FILES (RUN 521 & 546) FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS PACKAGE INSERT INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED FOR THE DISCREPANT SAMPLES (RUN 521 A06 AND RUN 546 A01). ANALYSIS OF THE CURVES SHOW THAT N1 AND N2 TARGETS OBTAINED A STRONG AMPLIFICATION WITHOUT ANOMALY SUGGESTING TRUE POSITIVE RESULTS. LIMIT OF DETECTION OF THE OTHER METHODS (ANTIGEN AND POST-MORTEM PCR ANALYSIS) USED MAY HAVE BEEN DIFFERENT, EXPLAINING THE DISCREPANCIES. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS, HOWEVER, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOT 1012622. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A POTENTIALLY FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT ARRIVED AT THE EMERGENCY UNIT, HAD A COVID AG TEST PERFORMED, AND THE RESULT WAS NEGATIVE. A SAMPLE WAS COLLECTED FOR PCR ANALYSIS AND THE PATIENT DIED WHILE WAITING FOR THE RESULT. THE RESULT OF THE PCR TEST ON THE BD MAX USING THE SARS COVID ASSAY WAS POSITIVE. THE FAMILY QUESTIONED THE RESULTS OF THE PCR TEST AND REQUESTED AN ADDITIONAL PCR TEST BE PERFORMED FROM LUNG PARENCHYMA DURING AN AUTOPSY. THE RESULT OF THIS TEST WAS NEGATIVE. ACCORDING TO THE HOSPITAL THE DEATH IS NOT DIRECTLY RELATED TO COVID OR MISTREATMENT DUE TO DISCREPANT RESULTS. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FROM LOCAL DISTRIBUTOR PRODUCT MANAGER: ''- FIRST PATIENT FROM 31.03 ENTERED IN EMERGENCY UNIT OF THE HOSPITAL; TESTED COVID AG AND NEG RESULT, THEN TESTED PCR FOR CONFIRMATION AND RESULT +. SECOND PATIENT FEW DAYS LATER EXPERIENCED IDENTICAL SITUATION. BOTH PATIENTS DIED AFTER FEW HOURS IN EMERGENCY UNIT AND RELATIVES WANTED TO CONFIRM THE PCR + FROM THE HOSPITAL SO THEY DECIDED TO DO THE AUTOPSY AND PCR FROM LUNG PARENCHYMA THAT WAS NEGATIVE FOR BOTH PATIENTS. FOR THE MOMENT , WHAT I KNOW IS THAT THE PATIENTS FAMILIES DO NOT ACCEPT PCR RESULT FROM HOSPITAL LAB (THE ¿+ ¿ PCR RESULTS ON BD MAX) AND I DO NOT KNOW HOW THE EXTRACTION OR PCR TESTS WHERE DONE IN THE INSTITUTE OF LEGAL MEDICINE AND THEY ALREADY OPENED AN OFFICIAL INVESTIGATION. ACCORDING TO THE HOSPITAL THE DEATHS ARE NOT DIRECTLY RELATED TO COVID OR MISTREATMENT DUE TO DISCREPANT RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647845 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1012622

    Patients

    Seq Age Sex Outcome Treatment
    1