BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10681129 · Received October 14, 2020

    Report

    Report Number
    1119779-2020-00730
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 24, 2020
    Report Date
    May 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. DUE TO UNKNOWN LOT# A DHR COULD NOT BE PERFORMED. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. 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 A POTENTIAL DISCREPANT RESULT WAS OBTAINED BY THE CUSTOMER. THE SAMPLE WAS TESTED ON THE VERITOR AND THE RESULT WAS NEGATIVE. THE CUSTOMER REINSERTED THE CARTRIDGE INTO ANOTHER ANALYZER AND THE RESULT WAS POSITIVE. THE CUSTOMER COLLECTED A NEW SAMPLE AND THE RESULTS WERE NEGATIVE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, WITH NO RESPONSE FROM THE CUSTOMER AT THIS TIME. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 02402810 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). EUA#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY A POTENTIAL DISCREPANT RESULT WAS OBTAINED BY THE CUSTOMER. THE SAMPLE WAS TESTED ON THE VERITOR AND THE RESULT WAS NEGATIVE. THE CUSTOMER REINSERTED THE CARTRIDGE INTO ANOTHER ANALYZER AND THE RESULT WAS POSITIVE. THE CUSTOMER COLLECTED A NEW SAMPLE AND THE RESULTS WERE NEGATIVE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, WITH NO RESPONSE FROM THE CUSTOMER AT THIS TIME. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146433 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 02402810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other