BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10703557 · Received October 20, 2020

    Report

    Report Number
    3006948883-2020-00576
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 17, 2020
    Report Date
    May 20, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS FOR BATCH NUMBER 0213905 TESTING OF RETENTION SAMPLES OF BATCH NUMBER 0213905, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#(B)(6) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY TWO (2) FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING A PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE TESTING WAS PERFORMED FOR EMPLOYEE SCREENING WITH NO KNOWN EXPOSURE. THE EMPLOYEES WERE SENT HOME TO SELF-QUARANTINE. THIS INCIDENT TRIGGERED FURTHER TESTING OF ALL RESIDENTS. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY TWO (2) FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING A PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE TESTING WAS PERFORMED FOR EMPLOYEE SCREENING WITH NO KNOWN EXPOSURE. THE EMPLOYEES WERE SENT HOME TO SELF-QUARANTINE. THIS INCIDENT TRIGGERED FURTHER TESTING OF ALL RESIDENTS. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170005 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0213905

    Patients

    Seq Age Sex Outcome Treatment
    1