BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST

    MDR report key: 23099947 · Received September 19, 2025

    Report

    Report Number
    2647876-2025-00639
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 13, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MLA
    UDI-DI
    00382904462529
    PMA / PMN Number
    K931374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MJK, MJM. D.4. MEDICAL DEVICE LOT: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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: BD QUALITY INITIATED AN INVESTIGATION ON CUSTOMER CLAIM OF FALSE POSITIVE RESULTS ON AFFIRM. BATCH HISTORY REVIEW WAS PERFORMED ON FINISHED PRODUCT AND ITS COMPONENTS WITH SATISFACTORY RESULTS. IN PROCESS AND QC TESTING WERE WITHIN SPECIFICATIONS. VISUAL INSPECTION WAS PERFORMED ON RETENTION SAMPLES WITH SATISFACTORY RESULTS. FUNCTIONAL AND SPECIFICITY TESTING WAS ALSO PERFORMED ON RETENTION SAMPLES WITH SATISFACTORY RESULTS. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED FOR AFFIRM FALSE POSITIVE. BD WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE POSITIVE GARDNERELLA VAGINALIS PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE POSITIVE GARDNERELLA VAGINALIS PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021756 BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST DNA PROBE, YEAST MLA BECTON DICKINSON CARIBE LTD. UNKNOWN 00382904462529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown