BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 24533805 · Received March 6, 2026

    Report

    Report Number
    3007420875-2026-00043
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 19, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904437121
    PMA / PMN Number
    K201017
    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: NSU, OUY, PQA. 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 OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE TEST WAS REPEATED ON BD MAX¿ CTGCTV2, AND THE RESULT WAS TV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435100 BD MAX¿ VAGINAL PANEL VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5171116 00382904437121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown