BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    MDR report key: 15157694 · Received August 3, 2022

    Report

    Report Number
    1119779-2022-01053
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 8, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES ¿DISCREPANT RESULTS¿ USING THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER 2031002. 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR DISCREPANT RESULTS. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ AT-HOME COVID-19 TEST (B)(4) THERE WAS A DISCREPANT RESULT. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 16 DAYS AGO HE TESTED POSITIVE PCR TEST. HE TESTED TODAY WITH BINEX AND THE BD VERITOR TEST. BINEX CAME BACK NEGATIVE AND BD VERITOR CAME BACK POSITIVE. THE CUSTOMER IS CONFUSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ AT-HOME COVID-19 TEST (EUA(B)(4))THERE WAS A DISCREPANT RESULT. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 16 DAYS AGO HE TESTED POSITIVE PCR TEST. HE TESTED TODAY WITH BINEX AND THE BD VERITOR TEST. BINEX CAME BACK NEGATIVE AND BD VERITOR CAME BACK POSITIVE. THE CUSTOMER IS CONFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902863 BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED QKP BECTON, DICKINSON & CO. (SPARKS) 2031002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown