BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ EXT ENTERIC BACTERIAL PANEL

    MDR report key: 24522856 · Received March 5, 2026

    Report

    Report Number
    3007420875-2026-00039
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 18, 2026
    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
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (XEBP) ASSAY (REF. (B)(4)) KIT LOT 5231261 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¿ XEBP LOT 5231261 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER QUESTIONED THE POSITIVE VIBRIO RESULTS FOR FOUR SAMPLES PROCESSED ON BD MAX¿ INSTRUMENT (B)(6): RUN 92 (A2), RUN 93 (A6), RUN 95 (B5), AND RUN 100 (A10), OBTAINED IN A SHORT PERIOD OF TIME (FROM FEBRUARY 6TH TO 8TH). PCR CURVE ADJUDICATION OF THE VIBRIO POSITIVE SAMPLES REVEALED LATE AND LOW BUT APPEARING TO BE TRUE VIBRIO POSITIVE AMPLIFICATIONS. LOW POSITIVES SAMPLES, SUCH AS THE ONES INVESTIGATED HEREIN CAN OCCUR DUE TO BACTERIAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THE TOTAL RATE OF POSITIVE VIBRIO SAMPLES FOR THE CURRENT COMPLAINT KIT LOT 5231261 IS 0.63% (15/2383) WHILE THE RATE OF ALL OTHER LOTS , USED BY THE CUSTOMER, IS 0.72% (6/835), SUGGESTING THE REAGENT IS NOT SUSPECTED TO BE AN ISSUE. 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 XEBP ASSAY LOT 5231261. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), AS WELL AS ENVIRONMENTAL OR CROSS CONTAMINATION COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULT. 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

    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¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO 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¿ EXT ENTERIC BACTERIAL PANEL, A VIBRIO FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584642 BD MAX¿ EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5231261 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown