BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST

    MDR report key: 23260123 · Received October 9, 2025

    Report

    Report Number
    2647876-2025-00644
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MLA
    PMA / PMN Number
    K931374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 446252, BATCH 5078961. QUALITY INITIATED AN INVESTIGATION ON CUSTOMER INQUIRY IN REGARDS OF DISCREPANT RESULTS, ON AFFIRM CATALOG 446252, BATCH 5078961, FALSE NEGATIVE RESULTS. BATCH HISTORY REVIEW WAS PERFORMED TO THE FINISHED PRODUCT AND ITS COMPONENTS, NO DEVIATION WAS REPORTED ON ANY RECORD. IN PROCESS AND QC TESTING WERE WITHIN SPECIFICATIONS. VISUAL INSPECTION WAS PERFORMED TO THE RETENTION SAMPLE WITH SATISFACTORY RESULTS. NO RETURNED GOODS SAMPLE WAS AVAILABLE. FUNCTIONAL TEST WAS PERFORMED WITH SATISFACTORY RESULTS. COMPLAINT IS UNCONFIRMED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MJK, MJM. 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

    REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE NEGATIVE CANDIDA PATIENT RESULT WAS OBTAINED. A CULTURE CONFIRMATION TEST GREW YEAST. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE NEGATIVE CANDIDA PATIENT RESULT WAS OBTAINED. A CULTURE CONFIRMATION TEST GREW YEAST. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552385 BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST DNA PROBE, YEAST MLA BECTON DICKINSON CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown