BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 21323902 · Received February 6, 2025

    Report

    Report Number
    3007420875-2025-00029
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 6, 2025
    Report Date
    May 22, 2025
    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
    CO, 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¿ ENTERIC VIRAL PANEL KITS (REF. 443985) LOTS 4233920 AND 4233917 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC VIRAL PANEL KITS INDICATED THAT LOTS 4233920 AND 4233917 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT TWO OCCURRENCES OF SUSPECTED FALSE POSITIVE RESULTS. CUSTOMER PROVIDED RUN FILES (PDF AND CSV) FOR RUNS 156, 192, 196, 198, 235, AND 236 FROM INSTRUMENT CT3350 FOR INVESTIGATION. HOWEVER, ONLY THE SAMPLES IDENTIFIED AS PROBLEMATIC BY THE CUSTOMER WERE ANALYZED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS POSITIVE RESULTS IN RUN 196, 198, 235, AND 236. THE FIRST SAMPLE, TESTED USING KIT LOT 4233917 IN RUN #196, POSITION A7, INITIALLY SHOWED POSITIVE RESULTS FOR NOV, ROV, AND ADV TARGETS. HOWEVER, IN THE REPEAT TEST DURING RUN #198, ONLY NOV REMAINED POSITIVE. ANALYSIS OF VIC CHANNEL FOR SAMPLE A7/RUN 196 REVEALED THE POSITIVE ADV TARGET RESULT WAS POTENTIALLY CAUSED BY AN INSTRUMENT ISSUE AFTER REVIEW BY A BD INSTRUMENT QUALITY ENGINEER. THIS INFORMATION WAS TRANSFERRED TO BD SERVICE FOR FURTHER INVESTIGATION AND A SERVICE CASE HAS BEEN OPENED ON THE INSTRUMENT CT3350. AS FOR THE ROV POSITIVE TARGET (FAM CHANNEL) IN RUN 196, THE PCR CURVE SHOWED LATE AND LOW AMPLIFICATION, APPEARING AS A TRUE POSITIVE RESULT. THIS AMPLIFICATION IS NOT SEEN IN THE REPEAT SAMPLE (RUN 198). THE SECOND SAMPLE, TESTED USING KIT LOT 4233920 IN RUN #235, POSITION B8 INITIALLY SHOWED POSITIVE RESULTS FOR NOV, SAV AND HASTV TARGETS, HOWEVER WHEN REPEATED IN RUN #236, ONLY NOV REMAINED POSITIVE. ANALYSIS OF THE PCR CURVES SHOWS STEP DISLOCATIONS IN RAW PCR SIGNALS FOR ROX, VIC AND CY5.5 CHANNELS AND GENERATED POSITIVE RESULTS FOR HASTV, SAV TARGETS AND THE INTERNAL CONTROL. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATIONS FOR THOSE TWO TARGETS AND A ROOT CAUSE COULD NOT BE IDENTIFIED. IN THE REPEAT RUN (#236), THERE IS NO AMPLIFICATION IN ROX AND VIC CHANNELS, CORRESPONDING TO HASTV AND SAV TARGETS. BOTH SAMPLES (RUN 196/A7 AND RUN 235/B8) SHOWED NO ANOMALY IN THE CURVES ASSOCIATED TO THE NOV POSITIVE RESULTS. THIS TARGET TESTED POSITIVE IN BOTH INITIAL AND REPEAT TESTS OF EACH SAMPLE. 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. BASED ON THIS INVESTIGATION, SAMPLE A7/RUN 196, THE ADV POSITIVE RESULT IS SUSPECTED TO BE CAUSED BY AN INSTRUMENT ISSUE AND A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE POSITIVE RESULT FOR THE ROV TARGET. FOR SAMPLE B8 IN RUN 235, NO ROOT CAUSE COULD BE IDENTIFIED TO EXPLAIN THE STEP DISLOCATIONS CAUSING THE SAV AND HASTV POSITIVE RESULTS. FINALLY, BOTH SAMPLES SHOWED NO ANOMALY IN THE CURVES ASSOCIATED TO THE NOV POSITIVE RESULTS. 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 LOTS 4233920 AND 4233917. 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. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    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

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A DISCREPANT PATIENT RESULT WAS OBTAINED. THE INITIAL TEST WAS POSITIVE FOR NOROVIRUS, SAPOVIRUS, AND ASTROVIRUS, AND THE REPEAT TEST WAS ONLY POSITIVE FOR NOROVIRUS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A DISCREPANT PATIENT RESULT WAS OBTAINED. THE INITIAL TEST WAS POSITIVE FOR NOROVIRUS, SAPOVIRUS, AND ASTROVIRUS, AND THE REPEAT TEST WAS ONLY POSITIVE FOR NOROVIRUS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918032 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233920 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown