BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12374457 · Received August 26, 2021

    Report

    Report Number
    1119779-2021-01433
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 FOR BD MAX SYSTEM (REF 444213) LOT K21-332 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. NO DATA WAS PROVIDED, AND NO OTHER INFORMATION PROVIDED, INCLUDING NO BD MAX¿ EXK¿ TNA-3 KIT LOT (USED IN COMBINATION WITH THE BD BIOGX SARS-COV-2 REAGENTS). THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. BIOGX REVIEW OF THE QUALITY CONTROL TESTING DATA INDICATES THAT KIT LOT K21-332 PERFORMS AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. CUSTOMER REPORTS FOUR PATIENT SAMPLES THAT INITIALLY TESTED POSITIVE WITH THE BD BIOGX SARS COV-2 ASSAY KIT LOT K21-332, BUT WHEN REPEATED, GAVE A NEGATIVE RESULT. ASIDE FROM THE INFORMATION AVAILABLE IN THE COMPLAINT TEXT, NO DATA WAS RECEIVED FROM THE CUSTOMER DESPITE MULTIPLE ATTEMPTS TO RECEIVE INFORMATION FROM THE CUSTOMER. BD WAS UNABLE TO CONFIRM THE CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BIOGX SARS-COV-2 FOR BD MAX SYSTEM LOT K21-332. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX AND BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 4 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). " IT WAS REPORTED THAT THERE WAS 4 FALSE POSITIVE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 4 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). "IT WAS REPORTED THAT THERE WAS 4 FALSE POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269791 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K21-332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown