BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12356808 · Received August 23, 2021

    Report

    Report Number
    3006948883-2021-00892
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 3, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING BD KIT VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 1153341. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE OR DISCREPANT RESULTS COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. RETURNED PRODUCT TESTING COULD NOT BE COMPLETED A SAMPLES ARE EXPIRED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE OR DISCREPANT RESULTS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING ON THE VERITOR AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: EUA (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER CALLED TO REPORT THAT THEIR VERITOR COVID KIT LOT.1153341 EXP.10/29/2021 IS GIVING OUT INCONSISTENT RESULTS."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING ON THE VERITOR AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER CALLED TO REPORT THAT THEIR VERITOR COVID KIT LOT. 1153341 EXP. 10/29/2021 IS GIVING OUT INCONSISTENT RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253868 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1153341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown