BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 22960532 · Received September 4, 2025

    Report

    Report Number
    3007420875-2025-00137
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 23, 2023
    Report Date
    July 8, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCI
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE TWO POTENTIAL LOT NUMBERS FOR THIS DEVICE: D4. MEDICAL DEVICE LOT #: 3137729. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 17-MAY-2023. D4. MEDICAL DEVICE LOT #: 3081371. D4. MEDICAL DEVICE EXPIRATION DATE: 12-OCT-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 22-MAR-2022. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4)) FROM LOTS 3137729 AND 3081371 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOTS 3137729 AND 3081371 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SUSPECTED STX FALSE POSITIVE RESULTS WHEN USING BD MAX¿ ENTERIC BACTERIAL PANEL KIT FROM LOTS 3081371 AND 3137729. CUSTOMER PROVIDED DATABASE FROM INSTRUMENT CT1164 FOR INVESTIGATION. SAMPLES A3, A5, A9, A12 AND B8 IN RUNS #3048 AND SAMPLES A1, A5 AND A9 IN RUN #3096 MENTIONED BY THE CUSTOMER IN THE COMPLAINT TEXT AS SUSPECTED STX FALSE POSITIVE. BOTH RUNS # 3048 AND #3096 WERE EXTRACTED AND MANUAL PCR CURVE ADJUDICATION OF THE SUSPECTED STX FALSE POSITIVE RESULTS WAS DONE. THE PCR CURVES ANALYSIS REVEALED THAT ALL THE STX POSITIVE RESULTS WERE LINKED TO ATYPICAL CURVES, AND UNLIKELY TRUE POSITIVES, EXCEPT FOR THE SAMPLE TESTED IN POSITION B8 (RUN 3048), WHICH APPEARS TO BE A TRUE STRONG STX POSITIVE SAMPLE. DATABASE ANALYSIS SHOWED THAT INSTRUMENT PUMP #1 PRESENTED A HIGHER UNRESOLVED RATE THAN THE OTHER PUMPS. THIS INFORMATION WAS TRANSFERRED TO BD SERVICE AND A COMPLAINT ON THIS INSTRUMENT IS ALREADY OPENED FOR FURTHER INVESTIGATION. DATA ANALYSIS DID NOT SUGGEST SPECIFIC LOTS LINKED TO POSITIVE RESULTS ISSUES. OVERALL, BASED ON THE INVESTIGATION AND DATA PROVIDED, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS ALTHOUGH AN INSTRUMENT RELATED ISSUE IS SUSPECTED OF BEING INVOLVED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOTS 3081371 AND 3137729. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334642 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) SEE H.11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown