BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 15161319 · Received August 3, 2022

    Report

    Report Number
    1119779-2022-01059
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 7, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QMN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1252913. 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED AND NO ISSUE WERE FOUND . RETURNED PRODUCT TESTING WAS COMPLETED AND ALL DEVICES HAD NORMAL INTENDED RESULTS. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ SARS-COV-2 & FLU A+B THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. THIS EVENT OCCURRED 2 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVE RESULTS ON 256088, LOT# 1252913". (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ SARS-COV-2 & FLU A+B THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. THIS EVENT OCCURRED 2 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVE RESULTS ON 256088, LOT# 1252913" EUA: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033562 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BECTON, DICKINSON & CO. (SPARKS) 1252913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown