BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ GBS

    MDR report key: 23302765 · Received October 15, 2025

    Report

    Report Number
    3007420875-2025-00183
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 4, 2025
    Report Date
    December 1, 2025
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN DOING NEGATIVE QC TESTING WITH THE BD MAX¿ GBS ASSAY (REF. 441772) LOT 5029165 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 5029165 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S FALSE POSITIVE RESULTS. CUSTOMER PROVIDED THE DATABASE FOR INSTRUMENT CT0264 ALONG WITH RUN FILES (PDF AND CSV) FOR RUNS 1576 AND 1577 FOR INVESTIGATION. THE DATABASE AND RUN FILES WERE REVIEWED BUT NO POSITIVE SAMPLE WAS FOUND WITH KIT LOT 5029165 AND NO INFORMATION ON THE SUSPECTED FALSE POSITIVE RESULTS WAS AVAILABLE EITHER. HOWEVER, OTHER KIT LOTS WERE FOUND TO HAVE POSITIVE RESULTS ON NEGATIVE CONTROL SAMPLES RECENTLY, NAMELY LOTS 5029035, 5044798 AND 5142282. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON TWO RANDOMLY SELECTED OF THOSE UNEXPECTED POSITIVE RESULTS (POSITION A2 IN RUN 1573 AND POSITION B4 IN RUN 1557), REVEALING LATE AND LOW, BUT TRUE, AMPLIFICATION OF THE GBS TARGET IN THE FAM CHANNEL FOR BOTH. MOREOVER, DATA ANALYSIS SUGGESTS THAT POSITIVE RESULTS IN NEGATIVE CONTROLS ARE NOT A NEW ISSUE FOR THIS CUSTOMER. SUCH RESULTS HAVE BEEN OBSERVED SINCE AT LEAST 2024 AND ACROSS MULTIPLE KIT LOTS, CONFIRMING THAT THE CUSTOMER¿S ISSUE IS NOT LOT SPECIFIC. A NEGATIVE RESULT UPON REPEAT WAS OBTAINED FOR ALL 24 UNEXPECTED POSITIVE RESULTS FOR NEGATIVE CONTROLS RECORDED SINCE 2024 ON INITIAL TEST. THIS SUGGESTS THAT THE ISSUE LIKELY OCCURS DURING THE PREPARATION OF THE TWO CONTROLS, POSITIVE AND NEGATIVE, AS THEY ARE ALWAYS TOGETHER IN THE SAME RUN. IN CONTRAST, THE REPEAT TESTS ALWAYS CONTAIN SOLELY THE DEFECTIVE NEGATIVE CONTROL. MOREOVER, A BD ASSOCIATE VISITING ON SITE MADE TWO RUNS ON (B)(6) 2025, ONE WITH KNOWN NEGATIVE PATIENT SAMPLES AND ONE FROM NEGATIVE CONTROL SAMPLES MADE USING 15UL OF LIM BROTH IN SBT, WITH A DIFFERENT KIT LOT, IN RUNS 1576 AND 1577, AND THE RESULTS WERE NEGATIVE. PRESENCE OF ONLY EXPECTED RESULTS IN THESE TWO RUNS SUGGESTS THE ISSUE MAY BE ISOLATED TO SPECIFIC EVENTS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, CROSS CONTAMINATION INTRODUCED DURING SAMPLES CONTROL PREPARATION AT THE CUSTOMER¿S SITE IS THE MOST LIKELY CAUSE TO EXPLAIN THE UNEXPECTED POSITIVE RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ GBS LOT 5029165. 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. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309396 BD MAX¿ GBS NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5029165 00382904417727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown