BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX ENTERIC VIRAL PANEL

    MDR report key: 11917022 · Received June 1, 2021

    Report

    Report Number
    3007420875-2021-00016
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 24, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904439859
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE KIT BD MAX¿ ENTERIC VIRAL PANEL (REF (B)(4) LOT 1026953 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC VIRAL PANEL INDICATED THAT THE LOT 1026953 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT INTERMITTENT FALSE POSITIVE RESULTS, NEGATIVE UPON RERUN, WITH THE BD MAX¿ ENTERIC VIRAL PANEL (EVP) KIT LOT 1026953 AND PROVIDED DATABASE OF INSTRUMENT CT1774 FOR INVESTIGATION. ONLY RUN FILES FROM RUNS 270, 314, 365, 368, 372 AND 422 WERE ANALYZED SINCE THE SUSPECTED FALSE POSITIVE RESULTS IDENTIFIED BY THE CUSTOMER WERE IN THOSE SPECIFIC RUNS. DATA ANALYSIS SHOWS THAT THREE OTHER KIT LOTS WERE USED WHEN THE SUSPECTED FALSE POSITIVE RESULTS WERE OBTAINED, SUGGESTING THAT THE ISSUE IS NOT RELATED TO A SPECIFIC KIT LOT. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED AND REVEALED A POTENTIAL NORMALIZER DRIFT ON THE INSTRUMENT CT1774 FOR RUNS 270, 314, 365, 368 AND 372. THE DATABASE WAS ALSO REVIEWED BY A BD INSTRUMENT QUALITY ENGINEER WHO CONFIRMED A POTENTIAL NORMALIZER DRIFT ON CT1774. A COMPLAINT WAS OPENED FOR THE NORMALIZER ISSUE (PR 3042178). FOR RUN 422 (POSITION A5, NOV TARGET), MANUAL PCR CURVE ADJUDICATION SHOWS THAT CURVE OF SAMPLE IN POSITION A5 IS NOT SIMILAR TO THE NORMALIZER DRIFT ISSUES OBSERVED IN RUNS 270, 314, 365, 368, 372. WITH THE DATA PROVIDED, BD WAS UNABLE TO IDENTIFY THE CAUSE OF THIS DISCREPANT RESULT, WHICH APPEARED TO BE AN ISOLATED EVENT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE KIT BD MAX¿ ENTERIC VIRAL PANEL LOT 1026953. THE ROOT CAUSE WAS NOT IDENTIFIED AND INSTRUMENT OPERATION IS STILL UNDER REVIEW. THE REAGENTS ARE NOT SUSPECTED OF BEING IN CAUSE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CONFIRMATORY TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER IS SEEING INTERMITTENT FALSE POSITIVE RESULTS WHICH ARE THEN NEGATIVE ON RE-RUN. ALSO HAD A NUMBER OF IND AND UNR RESULTS. NO INCORRECT RESULTS REPORTED AS POSITIVE RESULTS MUST BE CONFIRMED."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CONFIRMATORY TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS SEEING INTERMITTENT FALSE POSITIVE RESULTS WHICH ARE THEN NEGATIVE ON RE-RUN. ALSO HAD A NUMBER OF IND AND UNR RESULTS. NO INCORRECT RESULTS REPORTED AS POSITIVE RESULTS MUST BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812653 KIT BD MAX ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443985 UNKNOWN 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1