BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10759252 · Received October 29, 2020

    Report

    Report Number
    1119779-2020-00841
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 14, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (SELECT: MATERIAL # 256082 ), BATCH NUMBER WAS UNKNOWN OR INVALID. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS THE BATCH NUMBER WAS UNKNOWN OR IT WAS INVALID. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) # 1878253 TO FURTHER INVESTIGATE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE EMPLOYEE LEFT WORK AND THERE WAS NO PATIENT IMPACT OTHERWISE REPORTED. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 LOT #: 0233448 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE EMPLOYEE LEFT WORK AND THERE WAS NO PATIENT IMPACT OTHERWISE REPORTED. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224713 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0233448

    Patients

    Seq Age Sex Outcome Treatment
    1 Other