BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 22287248 · Received June 18, 2025

    Report

    Report Number
    3007420875-2025-00092
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 20, 2025
    Report Date
    August 27, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K214122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: PCH, PCI. 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 WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT (REF. 442963) LOT 4353348 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT SIX SAMPLES THAT GAVE DISCREPANT POSITIVE RESULTS FOR SALMONELLA (SALM) AND/OR CAMPYLOBACTER (CAMPY) TARGETS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 4353348. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL INDICATED THAT LOT 4353348 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN REPORTS (PDF) FOR RUNS 2601, 2602 AND 2603 FROM BD MAX¿ INSTRUMENT CT0506 FOR INVESTIGATION. CUSTOMER IDENTIFIED THE SIX DISCREPANT SAMPLES AS SAMPLES WITH LAST FOUR DIGITS *4901 (POSITIONS A7 (RUN 2601), A4 (RUN 2602), B2 (RUN 2603)), *0101 (POSITIONS B9 (RUN 2601), B4 (RUN 2602), B11 (2603)), *8501 (POSITIONS A10 (RUN 2601), B9 (RUN 2602), A1 (RUN 2603)), *2701 (POSITIONS B10 (RUN 2601), B12 (RUN 2602), A3 (RUN 2603)), *8401 (POSITIONS A9 (RUN 2601), B8 (RUN 2602), A9 (RUN 2603)) AND *0601 (POSITIONS B2 (RUN 2602), B10 (RUN 2603)). A LIMITED MANUAL PCR CURVE ADJUDICATION OF THE DISCREPANT SAMPLES FROM THE PDF REPORTS WAS PERFORMED AND REVEALED THAT ALL THE SAMPLES OBTAINED LATE AND LOW BUT TRUE AMPLIFICATION IN THE VIC CHANNEL (SALM TARGET) IN THEIR INITIAL RUNS. UPON REPEAT TESTING, SAMPLE *4901 OBTAINED LATE AND LOW BUT TRUE AMPLIFICATION IN THE FAM CHANNEL (CAMPY TARGET) BUT WAS NEGATIVE FOR THE SALM TARGET BOTH TIMES AND SAMPLE *0101 SHOWED LATE AND LOW AMPLIFICATION IN THE VIC CHANNEL (SALM TARGET) ON THE FIRST REPEAT TEST BUT WAS NEGATIVE ON THE SECOND REPEAT TEST, WHILE THE FOUR OTHER SAMPLES GAVE NEGATIVE RESULTS. ANALYSIS ALSO REVEALED A STRONG POSITIVE SAMPLE FOR THE SALM TARGET IN RUN 2601 (POSITION A5), AND IT IS SUSPECTED THAT CROSS-CONTAMINATION DURING SAMPLE PREPARATION COULD EXPLAIN THE CUSTOMER DISCREPANT RESULTS FOR THE SALM TARGET IN RUNS 2601 AND 2602. REGARDING SAMPLE *4901 WITH POSITIVE CAMPY TARGET RESULT IN RUNS 2602 AND 2603, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), AS WELL AS ENVIRONMENTAL CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 4353348. 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 PLAN SINCE NO NEW HAZARD OR TRENDS 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

    REPORT 5 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 5 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC BACTERIAL PANEL, A FALSE POSITIVE SALMONELLA PATIENT RESULT WAS OBTAINED. MAX TEST WAS REPEATED AND WAS SALMONELLA NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788766 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4353348 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown