BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22323812 · Received June 24, 2025

    Report

    Report Number
    3006948883-2025-00218
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 25, 2025
    Report Date
    June 11, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K132259, K132692, K151291, K152870, K160161 INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 3335314. THE CUSTOMER REPORTED THAT FOR 4 CARTRIDGES, THEY HAD NEGATIVE RESULT ON THE VERITOR ANALYZER FOR FLU A AND B, BUT THE CARTRIDGES SHOWED LINES FOR FLU A AND FLU B. 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 RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, A DISCREPANT PATIENT RESULT WAS OBTAINED. THE VERITOR ANALYZER PROVIDED NEGATIVE FLU A AND FLU B RESULTS; HOWEVER, THE USER VISUALLY READ THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULTS DUE TO OBSERVING LINES FOR FLU A AND FLU B. NO CONFIRMATORY TESTING WAS PERFORMED. THE SPECIMEN WAS RECOLLECTED AND NO HEALTH IMPACT OR FURTHER CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998476 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3335314 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown