BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13046330 · Received December 20, 2021

    Report

    Report Number
    1119779-2021-01999
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 23, 2021
    Report Date
    February 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM KIT (REF (B)(4)) LOT 1243693 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 MAXTM SYSTEM INDICATED THAT LOT 1243693 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SUSPECTED FALSE POSITIVE RESULTS WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1243693. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. ACCORDING TO THE INFORMATION PROVIDED, CUSTOMER OBTAINED DISCREPANT RESULTS IN THE INITIAL RUNS AND THE RETESTS PERFORMED WITH EITHER THE BD MAX¿ REAGENTS OR THE CEPHEID ASSAY. WITHOUT MORE INFORMATION, BD WAS UNABLE TO INVESTIGATE FURTHER, AND THE CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. OVERALL, BASED ON THE INVESTIGATION, NO REAGENTS 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 1243693. 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 THAT WHILE TESTING FOR SARS COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING PERFORMED WITH CEPHEID. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MAX 44500301_1243693 FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING PERFORMED WITH CEPHEID. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MAX 44500301_1243693 IS FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943573 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1243693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown