BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 23806304 · Received December 15, 2025

    Report

    Report Number
    3007420875-2025-00243
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 2, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904439859
    PMA / PMN Number
    K220607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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¿ ENTERIC VIRAL PANEL KIT (REF. 443985) LOT 5021181 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ ENTERIC VIRAL PANEL KIT LOT 5021181 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR VARIOUS TARGETS (ASTROVIRUS (HASTV), NOROVIRUS (NOV), ROTAVIRUS (ROV) AND SAPOVIRUS (SAV)) WITH THE BD MAX¿ ENTERIC VIRAL PANEL. ACCORDING TO CUSTOMER, THERE WAS NO REAL AMPLIFICATION OR NO SIGMOIDAL CURVES, AND SOMETIMES BUBBLES COULD BE OBSERVED IN CARTRIDGES. CUSTOMER PROVIDED RUN FILES (PDF AND CSV) OF RUN RUNS 775 AND 1246 FROM BD MAX¿ INSTRUMENT CT3221, RUN 481 FROM BD MAX¿ INSTRUMENT CT2365, AND RUN 484 FROM BD MAX¿ INSTRUMENT CT3307 FOR INVESTIGATION. SAMPLES IN RUN 775 IN POSITION B4, RUN 1246 IN POSITIONS A3 AND A7, RUN 481 IN POSITIONS A3, A5, A6 AND A9 AND IN RUN 484 IN POSITIONS A3, A7 AND A9 WERE IDENTIFIED AS THE SAMPLES INVOLVED IN CURRENT ISSUE. MANUAL PCR CURVE ADJUDICATION SHOWED TRUE AMPLIFICATION IN THE ROX CHANNEL FOR SAMPLES B4 (HASTV TARGET; RUN 775), A3 (HASTV TARGET; RUN 1246; FIGURE 1), A9 (NOV AND HASTV TARGETS; RUN 481) AND IN THE VIC CHANNEL FOR SAMPLE A3 (RUN 481). FOR THE REMAINING SAMPLES, STEP DISLOCATIONS IN MULTIPLE CHANNELS WERE OBSERVED, AND IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS. THESE RESULTS COULD BE RELATED TO THE BUBBLES THE CUSTOMER MENTIONED HAVING OBSERVED IN THE CARTRIDGES, SINCE MULTIPLE CHANNELS ARE IMPACTED AT THE SAME CYCLE. OVERALL, BD WAS UNABLE TO FIND THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS, BUT BASED ON THE INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC VIRAL PANEL ASSAY LOT 5021181. 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 (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL MEDICAL DEVICE TYPE: PCH. 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

    REPORT 10 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE ASTROVIRUS PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 10 OF 10: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WITH A WEEK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325682 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5021181 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown