BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    MDR report key: 21514986 · Received March 4, 2025

    Report

    Report Number
    3006948883-2025-00005
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560418
    PMA / PMN Number
    K120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K ARE AS FOLLOWS: G.4. PMA/510(K)#: K121797, K132256, K132693, K133138, K151301, K152874, K160164. 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

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL #: 256041), BATCH NUMBER 3274402. THE CUSTOMER REPORTED THAT THEY ARE RECEIVING DISCREPANT RESULTS. 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 PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT 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. 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 WHEN USING ONE (1) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, DISCREPANT FLU RESULTS WERE OBSERVED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. OTHER NON SPECIFIED TESTS PROVIDED POSITIVE FLU RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING ONE (1) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, DISCREPANT FLU RESULTS WERE OBSERVED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. OTHER NON SPECIFIED TESTS PROVIDED POSITIVE FLU RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189412 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3274402 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown