BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11803346 · Received May 10, 2021

    Report

    Report Number
    1119779-2021-00793
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 17, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 1033566 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE COMPLAINT WAS OPENED FOR LOT 1026938 BUT ANALYSIS OF THE RUN PROVIDED SHOWED THAT IT WAS PERFORMED USING LOT 1033566. THEREFORE, LOT 1033566 WAS INVESTIGATED IN THIS REPORT. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOT 1033566 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT ONE N1 POSITIVE SAMPLE WITH BD SARS-COV-2 REAGENTS KIT LOT 1026938 WHICH TESTED NEGATIVE WITH ANOTHER ASSAY (GENEXPERT, CEPHEID) AND PROVIDED RUN #343, PERFORMED ON INSTRUMENT CT2158 FOR INVESTIGATION (INSTEAD OF RUN 334, WHICH WAS THE RUN MENTIONED IN THE COMPLAINT TEXT, THE SAMPLE ID CORRESPONDED TO THE ONE MENTIONED IN THE COMPLAINT TEXT, AND RUN 343 WAS PRESUMED TO BE THE CORRECT RUN). THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD MAX SARS-COV-2 REAGENT¿S INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE DISCREPANT SAMPLE (RUN #343, POSITION B1). MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF THE PCR CURVE SHOW ATYPICAL JAGGED CURVES IN THE RAW PCR SIGNAL, ESPECIALLY IN THE FAM CHANNEL (N1 TARGET), RESULTING IN A POSITIVE RESULT. THE ROOT CAUSE OF THIS ATYPICAL CURVE COULD NOT BE IDENTIFIED, AND THE POSITIVE RESULT OBTAINED CANNOT BE CONFIRMED. OVERALL, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULT, HOWEVER NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX SARS-COV-2 REAGENTS LOT 1033566. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE WAS OBTAINED. CONFIRMATORY GENE XPERT TESTING WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUN 334. PATIENT ID (B)(6). N1 DETECTED POS. CT 31.3. CONFIRMED NEG ON GENE XPERT SAME DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE WAS OBTAINED. CONFIRMATORY GENE XPERT TESTING WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUN 334, PATIENT ID (B)(6), N1 DETECTED POS, CT 31.3, CONFIRMED NEG ON GENE XPERT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695585 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1026938

    Patients

    Seq Age Sex Outcome Treatment
    1