BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST

    MDR report key: 16073602 · Received December 29, 2022

    Report

    Report Number
    1119779-2022-01556
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    July 1, 2022
    Report Date
    March 9, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MLA
    UDI-DI
    00382904462529
    PMA / PMN Number
    K931374
    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

    QUALITY INITIATED AN INVESTIGATION ON TRICHOMONAS POSITIVE INCREASE CUSTOMER CLAIM ON MATERIAL 446252, BATCHES 2151435, 2175675, 2108240, 2129244, 2161623. FUNCTIONAL TEST SHOWED SATISFACTORY RESULTS WHEN RETENTION SAMPLES WERE TESTED. VISUAL INSPECTION WAS PERFORMED TO THE RETENTION WITH SATISFACTORY RESULTS. NO RETURNED GOODS SAMPLE WAS AVAILABLE. BATCH HISTORY RECORD REVIEW WAS PERFORMED TO THE FINISHED PRODUCT WITH SATISFACTORY RESULTS. IN PROCESS AND QC TESTING WERE WITHIN SPECIFICATIONS. COMPLAINT UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE LOT #:2077353, MEDICAL DEVICE EXPIRATION DATE: 2022-12-14, AND DEVICE MANUFACTURE DATE: 2022-03-18. MEDICAL DEVICE LOT #:2090679, MEDICAL DEVICE EXPIRATION DATE: 2023-01-24, AND DEVICE MANUFACTURE DATE: 2022-03-31. MEDICAL DEVICE LOT #:2129244, MEDICAL DEVICE EXPIRATION DATE: 2023-03-21, AND DEVICE MANUFACTURE DATE: 2022-05-09. MEDICAL DEVICE LOT #:2108240, MEDICAL DEVICE EXPIRATION DATE: 2023-03-14, AND DEVICE MANUFACTURE DATE: 2022-04-18. MEDICAL DEVICE LOT #:2151435, MEDICAL DEVICE EXPIRATION DATE: 2023-04-11, AND DEVICE MANUFACTURE DATE: 2022-05-31. MEDICAL DEVICE LOT #:2175675, MEDICAL DEVICE EXPIRATION DATE: 2023-05-17, AND DEVICE MANUFACTURE DATE: 2022-06-10. MEDICAL DEVICE LOT #:2161623, MEDICAL DEVICE EXPIRATION DATE: 2023-05-10, AND DEVICE MANUFACTURE DATE: 2022-06-10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST THAT THERE WAS FASLE POSITIVES. IT WAS REPORTED THAT 7 LOTS WERE INVOLVED. SEE H.10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFFIRM 446252 - KIT AFFIRM VPIII CLINICAL POSITIVE RATE INCREASE FOR TRICHOMONAS ASSAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST THAT THERE WAS FASLE POSITIVES. IT WAS REPORTED THAT 7 LOTS WERE INVOLVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFFIRM 446252 - KIT AFFIRM VPIII CLINICAL POSITIVE RATE INCREASE FOR TRICHOMONAS ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613193 BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST DNA PROBE, YEAST MLA BECTON, DICKINSON & CO. (SPARKS) 446252 2161623 00382904462529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown