BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19097736 · Received April 12, 2024

    Report

    Report Number
    3006948883-2024-00049
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560456
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. MULTIPLE 510(K): K112277, K132259, K132692, K151291, K152870, K160161. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS ALSO A SCRATCH ON THE CARTRIDGE IN THE REACTION WINDOW. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS ALSO A SCRATCH ON THE CARTRIDGE IN THE REACTION WINDOW. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579288 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. 2354126 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown