BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    MDR report key: 13339086 · Received January 24, 2022

    Report

    Report Number
    1119779-2022-00098
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 8, 2022
    Report Date
    March 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES ¿CUSTOMER RECEIVED A NEGATIVE TEST RESULT¿ WITH THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER UNKNOWN AND ¿A POSITIVE TEST RESULT LATER THAT DAY ON A SUBSEQUENT TEST¿. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL 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 BECAUSE A BATCH NUMBER WAS NOT PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VERITOR ¿ AT-HOME COVID-19 TEST HAS BEEN FOUND PRODUCING A FALSE NEGATIVE RESULT. EUA#210417 THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER RECEIVED A NEGATIVE TEST RESULT VIA THE VERITOR AT-HOME TEST KIT. CUSTOMER REPORTED RECEIVING A POSITIVE TEST RESULT LATER THAT DAY ON A SUBSEQUENT TEST.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VERITOR ¿ AT-HOME COVID-19 TEST HAS BEEN FOUND PRODUCING A FALSE NEGATIVE RESULT. EUA# (B)(4). THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER RECEIVED A NEGATIVETEST RESULT VIA THE VERITOR AT-HOME TEST KIT. CUSTOMER REPORTED RECEIVING A POSITIVE TEST RESULT LATER THAT DAY ON A SUBSEQUENT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241818 BD VERITOR ¿ AT-HOME COVID-19 TEST NA QKP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown