BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 16908335 · Received May 10, 2023

    Report

    Report Number
    3007420875-2023-00049
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 16, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    PCH
    UDI-DI
    00382904439859
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL ASSAY (REF. 443985) LOTS 2200258 AND 2229202 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC VIRAL PANEL INDICATED THAT LOTS 2200258 AND 2229202 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT RESULTS ON 4 SAMPLES WITH BD MAX¿ ENTERIC VIRAL PANEL (EVP) KITS FROM LOTS 2200258 AND 2229202. ACCORDING TO THE CUSTOMER, THEIR INITIAL TEST GAVE A POSITIVE RESULT FOR SOME VIRUSES AND WHEN REPEATED FROM THE ORIGINAL SAMPLES, THE RESULTS WERE DIFFERENT. CUSTOMER PROVIDED FOUR RUN FILES FOR INVESTIGATION (6029, 6031, 6041, 6042 FROM CT0615). MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON THE SAMPLES TAGGED BY THE CUSTOMER. THREE SAMPLES (A3, A4 AND A5) TESTED IN RUN 6029 GAVE POSITIVE RESULTS FOR MULTIPLE TARGETS BUT WHEN RETESTED IN RUN 6031, ONE SAMPLE GAVE A NEGATIVE RESULT AND THE TWO OTHERS GAVE A POSITIVE RESULT BUT FOR THE ROV TARGET ONLY. ANALYSIS REVEALED THAT DESPITE THE FLUORESCENCE INCREASE OBSERVED IN THE BACKGROUND CORRECTED CURVES AT CYCLE 25 IN THE ROX CHANNEL IN TOP POSITION (NOV TARGET), THERE IS NO AMPLIFICATION WHEN ANALYZED IN RAW, SUGGESTING THAT THE NOV POSITIVE RESULTS IN POSITIONS A3, A4 AND A5 ARE NOT TRUE POSITIVE RESULTS. THE SAME ISSUE WAS OBSERVED IN THE ROX CHANNEL IN BOTTOM POSITION, WHERE HAST POSITIVE RESULTS WERE OBTAINED BUT NO AMPLIFICATION WAS OBSERVED IN THE RAW CURVES. THIS IS UNLIKELY THAT THESE POSITIVE RESULTS WERE THE RESULT OF TRUE AMPLIFICATION. SAMPLE A5 IN RUN 6041 GAVE A ROV POSITIVE RESULT BUT WHEN RETESTED IN RUN 6042, IT GAVE A NOV POSITIVE RESULT. ANALYSIS SHOWED THAT THE ROV POSITIVE RESULT OBTAINED IN RUN 6041 WAS A LATE BUT APPEARED TO BE TRUE AMPLIFICATION, SUGGESTING A SAMPLE AT THE ASSAY LIMIT OF DETECTION OR A CONTAMINATION ISSUE AT THE CUSTOMER SITE. HOWEVER, THE NOV POSITIVE RESULT OBTAINED IN RUN 6042 (IN ROX TOP) FOR THIS SAMPLE, WAS NOT THE RESULT OF TRUE AMPLIFICATION. THE SIGNAL IN THE ROX CHANNEL DOES NOT SHOW ANY AMPLIFICATION WHEN ANALYZED IN RAW, WHICH IS INDICATIVE OF FALSE SIGNAL DETECTION. A BD INSTRUMENT QUALITY ENGINEER ALSO REVIEWED THE CURVES AND CONFIRMED THAT THE NOV AND HAST POSITIVE RESULTS WERE POTENTIALLY CAUSED BY A NORMALIZER DRIFT ON INSTRUMENT CT0615. AN INSTRUMENT SERVICE TICKET WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE. BASED ON THE INVESTIGATION, THERE IS NO REAGENT ISSUE 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 KIT LOTS 2200258 AND 2229202. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE REAGENT COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D1: MEDICAL DEVICE BRAND NAME: BD MAX¿ ENTERIC VIRAL PANEL H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 4 OF 4. IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC VIRAL PANEL THEY OBTAIN POSITIVE FOR SOME VIRUSES ON INITIAL RESULT AND ON REPEAT DIFFERENT VIRUSES ARE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPECIMENS ARE EITHER BEING POSITIVE FOR MULTIPLE VIRUSES OR BEING POSITIVE FOR ONE VIRUS THEN ON REPEATING THE SPECIMEN ITS POSITIVE FOR A DIFFERENT VIRUS.

    Description of Event or Problem · 0

    REPORT 4 OF 4 IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC VIRAL PANEL THEY OBTAIN POSITIVE FOR SOME VIRUSES ON INITIAL RESULT AND ON REPEAT DIFFERENT VIRUSES ARE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPECIMENS ARE EITHER BEING POSITIVE FOR MULTIPLE VIRUSES OR BEING POSITIVE FOR ONE VIRUS THEN ON REPEATING THE SPECIMEN ITS POSITIVE FOR A DIFFERENT VIRUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199399 BD MAX¿ ENTERIC VIRAL PANEL SEE H.10 PCH BECTON DICKINSON & CO. (SPARKS) 443985 2229202 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown