BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 22576020 · Received July 23, 2025

    Report

    Report Number
    3006948883-2025-00322
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    October 18, 2023
    Report Date
    June 12, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    UDI-DI
    00382902580881
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: ITEM IS ALSO EUA - EUA(B)(4). INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES MIX OF PRODUCT ISSUE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL#: 256088), BATCH NUMBERS: 3193518. THE CUSTOMER REPORTED THAT THEY ORDERED 5 TRIPLEX KITS AND TWO OF THE TRIPLEX KITS CAME WITH COVID ONLY TESTING CARTRIDGES, INSTEAD OF THE TRIPLEX TESTING CARTRIDGES. THE EXTRACTION TUBES WERE THE CORRECT COVID/FLU COMBO, ONLY THE CASSETTES WERE INCORRECT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE MIX OF PRODUCT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE ANALYSIS WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. THERE ARE NO RISKS OF PRODUCT MIX IDENTIFIED VIA BHR REVIEW AND RETENTION SAMPLE CHECK. NO PHYSICAL SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE CUSTOMER SHARED THE PHOTOGRAPHS OF AFFECTED KIT CONFIRMING THAT THEY RECEIVED COVID ONLY CARTRIDGES INSIDE INSTEAD OF THE TRIPLEX TEST CARTRIDGE IN THE TRIPLEX KITS. THIS COMPLAINT WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE. BASED ON THE INFORMATION PROVIDED AT THIS MOMENT, NO ROOT CAUSE WAS IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR MIX OF PRODUCT WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA: 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING VERITOR ¿ SARS-COV-2 & FLU A+B KITS, THERE WERE INCORRECT CARTRIDGES (BD VERITOR ¿ SARS-COV-2) CONTAINED IN THE KIT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871003 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3193518 00382902580881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown