BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 24261922 · Received February 4, 2026

    Report

    Report Number
    3007420875-2026-00008
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    October 30, 2025
    Report Date
    February 4, 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
    NZ
    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 5021182 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 5021182 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER REPORTED AN INCREASE IN POSITIVE RESULTS THAT WERE FOUND TO BE MOSTLY FALSE POSITIVE RESULTS AND PROVIDED RUN FILES (PDF AND CSV) OF RUN 1302 FROM BD MAX¿ INSTRUMENT CT2482 FOR INVESTIGATION. NO SAMPLES WERE IDENTIFIED BY THE CUSTOMER. THE SIX POSITIVE SAMPLES FOUND IN RUN 1302 WERE ANALYZED (B5, B6, B8, B9, B10, B11). MANUAL PCR CURVE ADJUDICATION SHOWED TRUE AMPLIFICATION FOR SAMPLE B5 IN THE FAM CHANNEL IN THE TOP POSITION OF THE CARTRIDGE (ROTAVIRUS (ROV) TARGET), SAMPLE B6 IN THE VIC CHANNEL IN BOTTOM POSITION OF THE CARTRIDGE (SAPOVIRUS (SAV) TARGET) AND SAMPLES B8/B9 IN THE FAM CHANNEL IN TOP POSITION OF THE CARTRIDGE (ROTAVIRUS (ROV) TARGET). HOWEVER, PRELIMINARY ANALYSIS FOR SAMPLES B8 TOP (ADENOVIRUS (ADV) TARGET) AND B9 TOP/BOTTOM (ADV AND SAV TARGETS RESPECTIVELY) SUGGESTS A POSSIBLE OPTICAL CROSSTALK ISSUE. IT IS UNLIKELY THESE POSITIVE RESULTS (B8 ADV POS AND B9 ADV AND SAV POS RESULTS) ARE TRUE AMPLIFICATIONS. THIS INFORMATION WAS TRANSFERRED TO BD SERVICE FOR FURTHER INVESTIGATION, AND A SERVICE CASE HAS BEEN OPENED ON THE INSTRUMENT CT2482. SAMPLES B10 AND B11, ON THE OTHER HAND, SHOWED STEP DISLOCATIONS IN MULTIPLE CHANNELS RESULTING IN FLUORESCENCE REACHING THE THRESHOLD TO GIVE A POSITIVE RESULT IN THE ROX CHANNEL, IN BOTTOM (ASTROVIRUS (HASTV) TARGET) AND TOP (NOROVIRUS (NOV) TARGET) POSITIONS OF THE CARTRIDGE, RESPECTIVELY. IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS. UNFORTUNATELY, NO ROOT CAUSE COULD BE IDENTIFIED BUT THE ISSUE SEEMED ISOLATED TO THESE TWO EVENTS. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND ABERRANT CURVE GEOMETRY ARE A CONSERVATIVE ASSESSMENT OF THE DATA. OVERALL, BASED ON THE DATA PROVIDED, BD WAS UNABLE TO FIND THE EXACT CAUSE OF WHY SOME OF THE CUSTOMER¿S POSITIVE RESULTS APPEAR TO BE FALSE. 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 5021182. 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.

    Description of Event or Problem · 0

    REPORT 4 OF 6: IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322650 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5021182 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown