BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CTGCTV2 (US)

    MDR report key: 23828493 · Received December 17, 2025

    Report

    Report Number
    3007420875-2025-00264
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 4, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439040
    PMA / PMN Number
    K182692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) FROM LOT 5183346 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS FOR THE NEISSERIA GONORRHOEAE (GC) TARGET FOR ONE SAMPLE WHICH WAS INITIALLY POSITIVE BUT GAVE NEGATIVE RESULTS UPON TWO RETESTS FROM SAME SBT. CUSTOMER PROVIDED RUNS 2844, 2845, 2847 AND 2848 FROM BD MAX¿ INSTRUMENT (B)(6) FOR INVESTIGATION. AFFECTED SAMPLES WERE FOUND IN POSITIONS B11 (GC POS) OF RUN 2844, B10 (GC NEG) OF RUN 2845 AND B10 (GC NEG) OF RUN 2847, WHEN TESTING THE SAME SAMPLE BUFFER TUBE (SBT) FROM INITIAL SAMPLE, AND IN POSITIONS B2 AND B12 (GC NEG) IN RUN 2848, WHEN TESTING RECOLLECTED SAMPLES. MANUAL PCR CURVES ADJUDICATIONS REVEALED LATE AND LOW BUT TRUE AMPLIFICATIONS IN THE VIC AND CY5.5 CHANNELS (GC TARGETS) FOR SAMPLE B11 (RUN 2844) AND GAVE A POSITIVE GC RESULT, WHILE AMPLIFICATION WAS ONLY OBSERVED IN THE VIC CHANNEL (GC TARGET) FOR SAMPLE B10 (RUN 2845), WHICH RESULTED IN A NEGATIVE GC RESULT SINCE BOTH TARGETS ARE REQUIRED TO GIVE A POSITIVE GC TARGET RESULT. NO AMPLIFICATION WAS OBSERVED IN THE VIC NOR THE CY5.5 CHANNELS FOR SAMPLES B10 (RUN 2847) AND B2/B12 (RUN 2848). NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 5183346. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. 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¿ CTGCTV2 (US), A FALSE POSITIVE GONORRHEA PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX TWICE AND WAS 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¿ CTGCTV2 (US), A FALSE POSITIVE GONORRHEA PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON BD MAX TWICE AND WAS NEGATIVE FOR BOTH. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247793 BD MAX¿ CTGCTV2 (US) MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5183346 00382904439040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown