BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 21323167 · Received February 6, 2025

    Report

    Report Number
    3007420875-2025-00028
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 5, 2025
    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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX VAGINAL PANEL (REF. 443712) KIT LOT 4234012 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED OBTAINING POSITIVE RESULTS THAT REPEATED NEGATIVE WHEN USING THE BD MAX VAGINAL PANEL (REF. 443712) KIT LOT 4234012. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX VAGINAL PANEL KIT INDICATED THAT LOT 4234012 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN 4141 FROM BD MAX INSTRUMENT CT3055 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE SAMPLE IN POSITION B7, IDENTIFIED AS THE UNEXPECTED POSITIVE RESULT IN THE COMPLAINT TEXT, AND REVEALED TRUE AMPLIFICATION WITHOUT ANOMALY FOR THE BV TARGET, WHEREAS CGROUP (ROX CHANNEL), CKRU (CY5 CHANNEL), CGLA (VIC CHANNEL), TV (FAM CHANNEL) TARGETS AND THE INTERNAL CONTROL (CY5.5 CHANNEL), ALL SHOWED ATYPICAL CURVES NOT INDICATIVE OF TRUE AMPLIFICATION. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR FALSE POSITIVE OR DISCREPANT RESULTS ON BD MAX VAGINAL PANEL KIT LOT 4234012. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT TESTING METHODS WHICH COULD EXPLAIN THE CUSTOMER'S ISSUE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ VAGINAL PANEL, A PATIENT RESULT WAS POSITIVE FOR MULTIPLE ORGANISMS. TEST WAS REPEATED AND WAS POSITIVE FOR ONLY ONE ORGANISM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ VAGINAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246904 BD MAX¿ VAGINAL PANEL VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4234012 00382904437121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown