BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10652813 · Received October 8, 2020

    Report

    Report Number
    1119779-2020-00493
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 17, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA #(B)(4). H6: INVESTIGATION SUMMARY 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. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WAS OBSERVED BY THE USER. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. NO RETURN SAMPLES WERE RECEIVED BY THE CUSTOMER. NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA)1878253 IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. A REPEAT TEST WAS PERFORMED USING PCR FOR ONE OF THE FALSE POSITIVES AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4).

    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. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. EUA#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR 8 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE INITIAL POSITIVE RESULT WAS DISCARDED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118446 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other