BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 24365864 · Received February 17, 2026

    Report

    Report Number
    3007420875-2026-00018
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 19, 2026
    Report Date
    April 1, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904439873
    PMA / PMN Number
    NA
    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 WHEN USING THE BD MAX¿ ENTERIC VIRAL PANEL-NR (REF. 443987) LOT 5142337 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ ENTERIC VIRAL PANEL-NR (EVP-NR) LOT 5142337 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER REPORTED FIVE SUSPECTED FALSE-POSITIVE RESULTS WHEN USING THE BD MAX¿ EVP-NR, FOR THE NOROVIRUS (NOV) TARGET. CUSTOMER PROVIDED RUN FILES (PDF) FOR RUNS 2122 AND 2126 FROM THE BD MAX¿ INSTRUMENT CT3243 FOR INVESTIGATION AND IDENTIFIED SAMPLES A2, A3, A5, A9 AND A10 IN RUN 2122 AS FALSE POSITIVE RESULTS FOR THE NOROVIRUS TARGET. CUSTOMER MENTIONED ALSO THAT ALL THE CURVES IN THE 585/530 CHANNEL (FOR NOROVIRUS TARGET) ARE ASCENDING AND THAT CT VALUE OF INTERNAL CONTROL (680/715 CHANNEL) IS TOO HIGH. THE CUSTOMER MENTIONED THAT IN CASE OF DOUBTFUL CURVES THEY REPEAT THE SAMPLE, IN THIS CASE FROM SAME SBT. HOWEVER, NO CORRELATION COULD BE MADE BETWEEN SAMPLES FROM RUNS 2122 AND 2126 PROVIDED BY THE CUSTOMER, RESULTS COULD THUS NOT BE COMPARED. THE CUSTOMER DID NOT MENTION ANY UNEXPECTED RESULTS IN RUN 2126 THUS, ONLY RUN 2122 WAS INVESTIGATED. PCR CURVE ANALYSIS OF RUN 2122 SHOWED LATE AND LOW AMPLIFICATION FOR SAMPLES A2, A3, A5 AND A9. LOW POSITIVE SAMPLES, SUCH AS THESE CAN OCCUR DUE TO VIRAL 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. AS WITH ALL PCR-BASED TESTS, EXTREMELY LOW LEVELS OF TARGET, BELOW THE LOD OF THE ASSAY, MAY BE DETECTED BUT RESULTS MAY NOT BE REPRODUCIBLE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA ANALYSIS AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULT FOR SAMPLES A2, A3, A5 AND A9. PCR CURVES ANALYSIS OF SAMPLE A10 IN PDF RUN 2122 SHOWED A TRUE POSITIVE AMPLIFICATION IN 585/530 (NOROVIRUS) CHANNEL. HOWEVER, NO AMPLIFICATION IS SEEN IN THE 680/715 (INTERNAL CONTROL) CHANNEL, AND THE ROTAVIRUS TARGET (475/520 CHANNEL) IS UNRESOLVED RESULT. THIS CAN HAPPEN IN CASE OF AN INHIBITORY SAMPLE. ACCORDING TO THE PACKAGING INSERT, THE BD MAX¿ SYSTEM REPORTS RESULTS FOR EACH TARGET INDIVIDUALLY AND AN UNR RESULT MAY BE OBTAINED FOR ONE OR MORE BD MAX¿ ENTERIC VIRAL PANEL TARGETS. IN THE CASE OF A PARTIAL UNR RESULT, WHEN ONE OR MORE TARGETS HAVE A POSITIVE RESULT AND ALL OTHER TARGETS HAVE A UNR RESULT, THE TEST SHOULD BE REPEATED. IN RARE CASES, DISCREPANT RESULTS MAY BE OBSERVED WHEN A REPEAT TEST IS RUN FOR THOSE TARGETS THAT WERE INITIALLY REPORTED AS POSITIVE RESULTS. IN THAT CASE, ANY POSITIVE RESULT IS RETAINED. BASED ON THE AVAILABLE DATA, CURVES ANALYSIS, AND CUSTOMER-PROVIDED INFORMATION, THE EXACT CAUSE OF THE OBSERVED ISSUES COULD NOT BE IDENTIFIED. HOWEVER, THE INVESTIGATION SUGGESTS THAT THE RESULTS ARE DUE EITHER TO SAMPLES AT OR NEAR THE ASSAY LOD, ENVIRONMENTAL, CROSS CONTAMINATION AND/OR INHIBITORY SAMPLES. 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-NR LOT 5142337. 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 SINCE NO TREND WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). D.2. 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

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NOROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE NOROVIRUS PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NOROVIRUS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107399 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5142337 00382904439873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown