BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ GROUP B STREPTOCOCCUS

    MDR report key: 23822560 · Received December 16, 2025

    Report

    Report Number
    3007420875-2025-00251
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 6, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904417727
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ GBS ASSAY (REF. (B)(4)) LOT 5142282 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ GBS ASSAY LOT 5142282 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S FALSE POSITIVE RESULTS. CUSTOMER PROVIDED RUN FILES OF RUNS 1690 (INITIAL RUN), 1691 (REPEAT TEST) AND 1698 (ENVIRONMENTAL MONITORING (EM)) FROM BD MAX¿ INSTRUMENT CT3088 FOR INVESTIGATION AND IDENTIFIED SAMPLES IN POSITIONS A3 TO A10 (RUN 1690) AS THE SUSPECTED FALSE POSITIVE SAMPLES. MANUAL PCR CURVE ADJUDICATION SHOWED EARLY AMPLIFICATION FOR SAMPLES A3 AND A9 IN THE FAM CHANNEL (GBS TARGET) IN RUN 1690 AND DURING THEIR REPEAT TEST DONE IN POSITIONS A3 AND A9 OF RUN 1691. THESE RESULTS APPEAR TO BE TRUE POSITIVE RESULTS, WITHOUT ISSUE. ON THE OTHER HAND, IN INITIAL (RUN 1690) AND REPEAT TEST RUNS (NEW SBT; RUN 1691), SAMPLES A4, A5, A6, A7, A8 AND A10 SHOWED LATE AMPLIFICATION IN THE FAM CHANNEL (GBS TARGET). SUCH LATE CT VALUES ARE UNEXPECTED WITH THE GBS ASSAY, SINCE SAMPLES ARE TESTED FOLLOWING AN ENRICHMENT STEP. CONSIDERING CUSTOMER MENTIONED IT WAS THEIR FIRST DAY OF RUNNING THE GBS ASSAY, IT IS SUSPECTED CROSS-CONTAMINATION OCCURRED DURING SAMPLE PREPARATION. BASED ON THE DATA AND INFORMATION PROVIDED, CROSS CONTAMINATION OR SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. HOWEVER, ALTHOUGH BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE ISSUE, 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¿ GBS LOT 5142282. 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 SINCE NO NEW HAZARD WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: NJR. 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¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687779 BD MAX¿ GROUP B STREPTOCOCCUS NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5142282 00382904417727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown