BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    MDR report key: 22548786 · Received July 18, 2025

    Report

    Report Number
    3006948883-2025-00309
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    February 20, 2024
    Report Date
    June 12, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560456
    PMA / PMN Number
    K112277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K132259, K132692, K151291, K152870, K160161 INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 2352688. THE CUSTOMER REPORTED THAT THEY ARE SEEING LINES ON THE DEVICE BUT RECEIVING NEGATIVE RESULTS ON THE VERITOR ANALYZER. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOGRAPHS OR RETURN SAMPLES WERE RECEIVED; THEREFORE, NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. "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 WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE INSTRUMENT GAVE A NEGATIVE RESULT HOWEVER THE CUSTOMER SAW LINES AND QUESTIONED THIS RESULT. THE TEST WAS REPEATED ON ANOTHER ANALYZER WITH A NEW CARTRIDGE AND WAS ALSO RECEIVED A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574721 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 2352688 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown