BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 20478043 · Received October 17, 2024

    Report

    Report Number
    3007420875-2024-00100
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 20, 2024
    Report Date
    January 25, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: PCH E.1. INITIAL REPORTER PHONE NUMBER : (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WITH THE BD MAX¿ ENTERIC VIRAL PANEL KIT (REF. (B)(4) LOT 4121697 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER SUSPECTS FALSE POSITIVE RESULTS FOR SAPOVIRUS (SAV) TARGET WHEN USING THE BD MAX¿ ENTERIC VIRAL PANEL KIT LOT 4121697. THEY CHALLENGE THE RESULT AS THE CURVE LOOKS TOO WEAK WHEN COMPARED WITH THE INTERNAL CONTROL SIGNAL. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ ENTERIC VIRAL PANEL INDICATED THAT LOT 4121697 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN 9694 FROM INSTRUMENT CT1949 FOR INVESTIGATION. MANUAL CURVE ADJUDICATION WAS CONDUCTED ON THE SAV POSITIVE SAMPLE (POSITION A6) AND REVEALED AN ATYPICAL AMPLIFICATION CURVE. DESPITE ITS ATYPICAL APPEARANCE, IT APPEARS TO BE A TRUE SAPOVIRUS POSITIVE RESULT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL OR ABERRANT CURVE GEOMETRY 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¿ ENTERIC VIRAL PANEL KIT AND THERE IS NO OTHER COMPLAINT ON LOT 4121697 FOR DISCREPANT RESULT. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION COULD EXPLAIN THE WEAK POSITIVE RESULT. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE SAPOVIRUS PATIENT RESULT WAS OBTAINED. THE PCR CURVE WAS ATYPICAL SO THE CUSTOMER DID NOT REPORT THE RESULT. 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 FALSE POSITIVE SAPOVIRUS PATIENT RESULT WAS OBTAINED. THE PCR CURVE WAS ATYPICAL SO THE CUSTOMER DID NOT REPORT THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271119 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4121697 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown