BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 14782246 · Received June 22, 2022

    Report

    Report Number
    1119779-2022-00926
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    June 6, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: (B)(4) A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT (REF. (B)(4) LOT 2011749 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM INDICATED THAT LOT 2011749 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE CUSTOMER RECENTLY OBSERVED THAT SOME POSITIVE RESULTS DISPLAYED A LATER N1 TARGET CT VALUE, BY 3 TO 4 CYCLES, COMPARED TO THE N2 TARGET CT, WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT 2011749. ACCORDING TO THEM, THE N1 AND N2 TARGETS USUALLY ALWAYS DISPLAY SIMILAR CT VALUES. CUSTOMER PROVIDED DATABASE FROM INSTRUMENT CT2204 FOR INVESTIGATION. THE CUSTOMER¿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¿S CT DIFFERENCE OBSERVED BETWEEN N1 AND N2 TARGETS WERE IN NORMAL TEST CT VARIATIONS. SPECIFIC SAMPLES MAY GENERATE DIFFERENT RESULTS COMPARED TO OTHERS. BD WAS UNABLE TO IDENTIFY THE CAUSE OF CUSTOMER ISSUE NOR CONFIRM WHAT WAS OBSERVED BY THE CUSTOMER, BUT NO REAGENT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD SARS-COV-2 REAGENTS FOR BD MAX LOT 2011749. 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. SEE H. 10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM AND INCREASE IN FALSE POSITIVES WAS OBSERVED. THIS IS A REPORT OF ONE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR REPORTED TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSTRUMENT MAX CLINICAL CUSTOMER REPORTS DISCREPANT RESULTS WHILE USING BD MAX SARS-COV-2 - CAT # 44500301 LOT # 2011749.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM AND INCREASE IN FALSE POSITIVES WAS OBSERVED. THIS IS A REPORT OF ONE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR REPORTED TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSTRUMENT MAX CLINICAL CUSTOMER REPORTS DISCREPANT RESULTS WHILE USING BD MAX SARS-COV-2 - CAT # 44500301 LOT # 2011749.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329005 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 2011749

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown