BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 23572558 · Received November 17, 2025

    Report

    Report Number
    3007420875-2025-00221
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 27, 2025
    Report Date
    February 5, 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

    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 5050864 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED A DISCREPANT RESULT FOR THE TRICHOMONAS VAGINALIS (TV) TARGET WITH BD MAX¿ VAGINAL PANEL KIT. INITIAL TEST GAVE A POSITIVE TV TARGET RESULT, WHILE REPEAT TEST GAVE A NEGATIVE TV TARGET RESULT. CUSTOMER ALSO TESTED THE SAME PATIENT TWICE WITH BD CTGCTV2 FOR BD MAX¿ SYSTEM AND GAVE A NEGATIVE TV TARGET RESULT IN BOTH TIMES. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ VAGINAL PANEL LOT 5050864 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER PROVIDED DATABASES FROM BD MAX¿ INSTRUMENTS CT2342 AND CT2473 AND SEVERAL RUN FILES FOR INVESTIGATION. THE CUSTOMER PERFORMED THE FIRST TEST ON THE CT2342 ON (B)(6). THE AFFECTED SAMPLE WAS FOUND IN RUN 2268 IN POSITION A9. REPEAT TEST WAS PERFORMED FROM THE SAME SBT, IN RUN 2140/POSITION B2 ON INSTRUMENT CT2473, ON (B)(6). MANUAL PCR CURVE ADJUDICATION FOR SAMPLE A9/RUN 2268 SHOWED TRUE AMPLIFICATION FOR THE TV TARGET WHILE SAMPLE B2/RUN 2140 SHOWED NO AMPLIFICATION FOR THE TV TARGET (FAM CHANNEL BOTTOM POSITION OF THE CARTRIDGE FOR VAGINAL PANEL). THE SAME PATIENT WAS ALSO TESTED WITH BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT USING ANOTHER SAMPLE BUFFER TUBE, AND BOTH TESTS GENERATED NEGATIVE TV TARGET RESULTS. THE CORRESPONDING AMPLIFICATION CURVES WERE FLAT ON BOTH INSTRUMENTS. ACCORDING TO THE BD MAX¿ VAGINAL PANEL IFU, A REPEAT SHOULD ONLY BE DONE WHEN THE RESULT IS IND, INC, OR UNR (FOR ONE OR MORE TARGETS), A STATEMENT NOT FOLLOWED BY THE CUSTOMER. MOREOVER, CUSTOMER MENTIONED DISCREPANCIES BETWEEN EACH TEST. IT MUST BE NOTED THAT ACCORDING TO THE CTGCTV2 ASSAY IFU REPEAT TESTING FROM A SINGLE BD MOLECULAR SAMPLE BUFFER TUBE MUST BE PERFORMED ON THE SAME BD MAX¿ SYSTEM AS THE ORIGINAL TEST. INDEED, THE INSTRUMENT ADJUSTS THE PIPETTING HEIGHT BASED ON THE NUMBER OF TESTS PERFORMED WITH A SINGLE SBT. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ VAGINAL PANEL KIT LOT 5050864. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), AND IMPROPER PROCEDURE FOR REPEAT TESTING, ARE BOTH SUSPECTED OF HAVING CONTRIBUTED TO THE CUSTOMER¿S DISCREPANT RESULTS. 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 WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE POSITIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. A REPEAT BD MAX¿ VAGINAL PANEL TEST WAS RUN AND WAS TV NEGATIVE. A NEW PATIENT SAMPLE WAS COLLECTED AND WAS TESTED TWICE ON BD MAX¿ CTGCTV2 AND WAS TV NEGATIVE FOR BOTH. 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 FALSE POSITIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. A REPEAT BD MAX¿ VAGINAL PANEL TEST WAS RUN AND WAS TV NEGATIVE. A NEW PATIENT SAMPLE WAS COLLECTED, AND WAS TESTED TWICE ON BD MAX¿ CTGCTV2 AND WAS TV NEGATIVE FOR BOTH. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12702 BD MAX¿ VAGINAL PANEL VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5050864 00382904437121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown