BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL

    MDR report key: 20267584 · Received September 20, 2024

    Report

    Report Number
    3007420875-2024-00080
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 13, 2024
    Report Date
    November 1, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904438128
    PMA / PMN Number
    K214122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. 443812) LOT: 4051425 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A DISCREPANT RESULT THAT TESTED POSITIVE WHEN USING THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT: 4051425 BUT WAS TESTED NEGATIVE BY AN EXTERNAL LABORATORY. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOT: 4051425 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN 262 FROM INSTRUMENT CT3207 FOR INVESTIGATION. CUSTOMER DESIGNATED AS TO INVESTIGATE SAMPLE IN RUN 262; POSITION A2 THAT TESTED POSITIVE FOR ETEC TARGET BUT CAME BACK NEGATIVE WHEN TESTED BY AN EXTERNAL LABORATORY. MANUAL PCR CURVE ADJUDICATION OF THE POSITIVE SAMPLE SHOWS LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR ETEC. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA BUT BASED ON THE ANALYSIS. THE LATE POSITIVE RESULTS COULD EXPLAIN THE DISCREPANCY WITH THE REFERENCE LABORATORY. IT MUST BE NOTED THAT LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NO INFORMATION WAS PROVIDED ABOUT THE ANALYSIS METHOD USED BY THE EXTERNAL LABORATORY. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT: 4051425. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, AND VARIATION BETWEEN ASSAYS ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. 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 QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    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¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT ENTEROTOXIGENIC E. COLI (ETEC) RESULT WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE (B)(6), AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT ENTEROTOXIGENIC E. COLI (ETEC) RESULT WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE (B)(6) DEPT. OF PUBLIC HEALTH (IDPH), AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392954 BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4051425 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown