BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 24607720 · Received March 16, 2026

    Report

    Report Number
    3007420875-2026-00055
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 25, 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
    LA, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ VAGINAL PANEL (REF. 443712) LOT 5171116 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ VAGINAL PANEL LOT 5171116 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE CUSTOMER REPORTED A SUSPECTED FALSE POSITIVE RESULT FOR THE TRICHOMONAS VAGINALIS (TV), CANDIDA GLABRATA (CGLA) AND CANDIDA SPP. (CGROUP) TARGETS WITH BD MAX¿ VAGINAL PANEL (REF#443712) KIT LOT 5171116. ALL TARGETS WERE NEGATIVE UPON RETESTING. ANOTHER SWAB COLLECTED FROM THE SAME PATIENT WAS TESTED WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM (REF#443904) KIT LOT 5204477 AND WAS NEGATIVE ON ALL TARGETS. THE CUSTOMER PROVIDED THE DATABASE OF INSTRUMENT CT3541 FOR INVESTIGATION. ONE SWAB WAS TESTED WITH THE BD MAX¿ VAGINAL PANEL ASSAY (RUN 59 POSITION B11) AND GAVE A POSITIVE RESULT FOR TV, C.GLA AND C.GROUP TARGETS, WHILE THE OTHER WAS TESTED WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM ASSAY (RUN 59 POSITION A9) AND GAVE A NEGATIVE TV RESULT. THE SAMPLE BUFFER TUBE (SBT) USED FOR THE BD MAX¿ VAGINAL PANEL ASSAY WAS RETESTED IN RUN 60 POSITION A2, USING THE SAME ASSAY AS IN THE ORIGINAL TEST. IN THIS REPEAT RUN, ALL TARGETS PRODUCED NEGATIVE RESULTS. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED FOR ALL THREE SAMPLES. FOR THE INITIAL BD MAX¿ VAGINAL PANEL SAMPLE (RUN 59 POSITION B11), WHICH WAS POSITIVE FOR TV, C.GLA AND C.GROUP TARGETS, THE AMPLIFICATION CURVES IN THE FAM CHANNEL (TV TARGET), VIC CHANNEL (C.GLA TARGET) AND ROX CHANNEL (C.GROUP TARGET) SHOWED STEP-DISLOCATIONS IN EVERY CHANNEL, WITH SIMILAR PATTERNS. THESE ATYPICAL CURVES DO NOT SUGGEST TRUE AMPLIFICATION. FOR THE RETEST WITH THE BD MAX¿ VAGINAL PANEL (RUN 60 POSITION A2), THE RESULT SHOWED NO AMPLIFICATION ON ALL TARGETS EXCEPT FOR THE INTERNAL CONTROL (CY5.5) AS EXPECTED. FURTHERMORE, THE BD CTGCTV2 FOR BD MAX¿ SYSTEM ASSAY (RUN 59 POSITION A9) DISPLAYED NO AMPLIFICATION FOR ALL TARGETS, INCLUDING THE TV TARGET, EXCEPT FOR THE INTERNAL CONTROL (ROX) AS EXPECTED. IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. ALTHOUGH, BASED ON THE DATA AND INFORMATION PROVIDED, NO ROOT CAUSE WAS IDENTIFIED AND UPON INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ VAGINAL PANEL LOT 5171116. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ CTGCTV2 AND GAVE A TV NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX¿ CTGCTV2 AND GAVE A TV NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669473 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