BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 23707558 · Received December 3, 2025

    Report

    Report Number
    3007420875-2025-00233
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 16, 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

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR TWO DISCREPANT SAMPLES WHEN USING THE BD MAX¿ VAGINAL PANEL (REF. (B)(6)) 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 THAT THE FIRST SAMPLE (ACCESSION ID WITH THE LAST THREE DIGITS *762) WAS CGROUP POSITIVE IN THE INITIAL RUN BUT NEGATIVE FOR ALL TARGETS AT THE RETEST, WHILE THE SECOND SAMPLE (ACCESSION ID WITH THE LAST THREE DIGITS *082) WAS ONLY CGROUP POSITIVE IN THE INITIAL RUN BUT CGROUP AND BV POSITIVE AT THE RETEST, WHEN TESTING UNKNOWN POSITIVE/NEGATIVE PATIENT SAMPLES AS CONTROLS FOR CORRELATION TESTING BETWEEN THEIR TWO BD MAX INSTRUMENTS. SPECIMENS WERE FIRST TESTED ON BD MAX INSTRUMENT (B)(6); RUN 2304, THEN REPEATED ON (B)(6); RUN 2176, USING THE SAME SBT SAMPLES, THESE BOTH RUNS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. IN RUN 2304, THE FIRST SAMPLE WITH LAST THREE DIGITS *762, WAS FOUND IN POSITION B1 AND THE SECOND DISCREPANT SAMPLE WITH LAST THREE DIGITS *082, WAS FOUND IN POSITION B2. MANUAL PCR CURVES ADJUDICATION FOR SAMPLE B1 SHOWED LATE AND LOW, BUT TRUE AMPLIFICATION FOR THE CGROUP TARGET WHILE SAMPLE B2 SHOWED NORMAL AMPLIFICATION (ROX CHANNEL BOTTOM POSITION OF THE CARTRIDGE). FOR BOTH SAMPLES, THE SIGNALS WERE ABOVE THE REQUIRED THRESHOLD, SHOWED NO ANOMALY AND CONFIRMED THE POSITIVE RESULT FOR THE CGROUP TARGET. THE CUSTOMER REPORTED DISCREPANCY BECAUSE SAMPLE *762 GAVE A NEGATIVE RESULT FOR THE CGROUP TARGET UPON REPEAT, IN RUN 2176 ON (B)(6). HOWEVER, NO ANOMALY WAS OBSERVED IN THE REPEAT TEST, WITH FLAT CURVE AND NO AMPLIFICATION. NEVERTHELESS, 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. BASED ON THE DATA ANALYSIS AND INFORMATION PROVIDED, A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULT BETWEEN INITIAL AND REPEAT TEST OF THAT SAMPLE. FOR THE OTHER DISCREPANT SAMPLE (*082), A POSITIVE RESULT WAS OBTAINED FOR THE CGROUP TARGET IN THE INITIAL TEST, BUT IT ALSO GENERATED A POSITIVE RESULT FOR THE BV TARGET, ALONG WITH A POSITIVE CGROUP TARGET RESULT, UPON REPEAT TESTING ON (B)(6) (A5; RUN 2176). MANUAL PCR CURVES ADJUDICATION FOR THIS SAMPLE SHOWED SIMILAR AMPLIFICATION FOR GARDNERELLA VAGINALIS AND ATOPOBIUM VAGINAE TARGETS IN BOTH TESTS. HOWEVER, IN THE REPEAT TEST, THE AMPLIFICATION OF LACTOBACILLUS SPP. (ROX CHANNEL TOP POSITION OF THE CARTRIDGE) WAS SLIGHTLY HIGHER THAN IN THE INITIAL TEST, REACHING THE THRESHOLD REQUIRED TO GIVE A BV POSITIVE RESULT, ALTHOUGH THE EP FLUORESCENCE SIGNAL REMAINS LOW. THE FACT THAT THE FLUORESCENCE DID NOT REACH THE THRESHOLD IN THE INITIAL TEST, AND ONLY SLIGHTLY HIGHER IN THE REPEAT, INDICATES THE SAMPLE IS AT THE LIMIT OF DETECTION OF THE ASSAY, EXPLAINING WHY ONLY THE INITIAL TEST WAS NEGATIVE. CUSTOMER MENTIONED DISCREPANCIES BETWEEN EACH TEST, WHILE USING TWO DIFFERENT INSTRUMENTS TO TEST THE SAME SAMPLE BUFFER TUBES. AS WITH ALL PCR-BASED TESTS, LOW LEVELS OF TARGET BELOW THE LOD OF THE ASSAY MAY BE DETECTED, BUT RESULTS MAY NOT BE REPRODUCIBLE. THIS PARTICULARITY COULD EXPLAIN, AT LEAST IN PART, SOME OF THE DISCREPANCIES OBSERVED DURING REPEAT TESTING, ESPECIALLY IN THE PRESENCE OF LOW-LOAD SAMPLES. 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. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS SUSPECTED OF HAVING CONTRIBUTED TO THE CUSTOMER¿S DISCREPANT RESULTS. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. 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.

    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 BV DISCREPANT PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. INITIAL TEST WAS BV NEGATIVE, AND THE REPEAT TEST ON A DIFFERENT BD MAX¿ INSTRUMENT WAS BV POSITIVE. 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 BV DISCREPANT PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. INITIAL TEST WAS BV NEGATIVE, AND THE REPEAT TEST ON A DIFFERENT BD MAX¿ INSTRUMENT WAS BV POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185601 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