BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX ENTERIC VIRAL PANEL

    MDR report key: 12028751 · Received June 18, 2021

    Report

    Report Number
    3007420875-2021-00020
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 27, 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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL ASSAY (REF. 443985) LOT 1033573 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. ALTHOUGH NO KIT LOT WAS ORIGINALLY PROVIDED, ANALYSIS OF THE CUSTOMER DATA REVEALED THAT BD MAX¿ ENTERIC VIRAL PANEL LOT 1033573 WAS USED TO TEST THE SUSPECTED FALSE POSITIVE SAMPLES AND WAS THUS INVESTIGATED. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC VIRAL PANEL INDICATED THAT THE LOT 1033573 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT FALSE POSITIVE RESULTS WITH THE BD MAX¿ ENTERIC VIRAL PANEL (EVP) ASSAY. THEY OBTAINED 5 LATE ROTAVIRUS POSITIVE RESULTS IN A RUN AND WHEN RETESTED, THEY ALL GAVE A NEGATIVE RESULT. CUSTOMER PROVIDED TWO RUNS FOR INVESTIGATION (RUN 3591 AND 3593) FROM INSTRUMENT CT0583. OUT OF 16 SAMPLES TESTED IN RUN 3591, THEY OBTAINED 7 ROTAVIRUS POSITIVE RESULTS, INCLUDING 2 STRONG RESULTS AND 5 LATE POSITIVE RESULTS. WHEN RETESTED IN RUN 3593, USING EITHER A NEW SAMPLE PREPARATION FROM THE ORIGINAL SAMPLE OR THE SAME SBT, ALL 5 LATE POSITIVE RESULTS GAVE A NEGATIVE RESULT. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE SEVEN SUSPECTED FALSE POSITIVE SAMPLES . THE CURVES OF ALL 7 SAMPLES SHOW TRUE AMPLIFICATION OF THE ROTAVIRUS TARGET BUT LATE AMPLIFICATION WAS OBTAINED FOR 5 OF THESE SAMPLES, WITHOUT ANOMALY IN THE RAW CURVES (CT BETWEEN 34.3 AND 38.3 FOR THE LATE POSITIVE RESULTS). LOW POSITIVE SAMPLES 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. SUCH LOW POSITIVE SAMPLES CAN GIVE A NEGATIVE RESULT WHEN RETESTED, WHICH COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S LATE POSITIVE RESULTS BUT CROSS CONTAMINATION IS PROBABLE SINCE STRONG POSITIVE SAMPLES WERE ALSO PROCESSED FOR THE SAME RUN. OVERALL, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX ENTERIC VIRAL PANEL LOT 1033573. THE ROOT CAUSE WAS NOT IDENTIFIED BUT CROSS CONTAMINATION AT CUSTOMER SITE IS STRONGLY SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE TOTAL 16 TESTS IN A RUN (CT0583, #3591) AND THERE WAS 1 STRONG POSITIVE CASE FOR ROTA VIRUS AND 5 LOW POSITIVE CASES FOR ROTA VIRUS IN THE SAME RUN. SO THE USER RE-RUN (#3593) THE 5 LOW POSITIVE CASES. TWO OF THEM WERE RUN WITH BOTH ORIGINAL BUFFER TUBE AND ORIGINAL SPECIMENS. 5 OF THEM WERE RUN WITH THE ORIGINAL SPECIMEN ONLY. ALL OF THE 7 TESTS WERE NEGATIVE AND THESE MEANS THEY ARE FALSE POSITIVE. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE TOTAL 16 TESTS IN A RUN (CT0583, #3591) AND THERE WAS 1 STRONG POSITIVE CASE FOR ROTA VIRUS AND 5 LOW POSITIVE CASES FOR ROTA VIRUS IN THE SAME RUN. SO THE USER RE-RUN (#3593) THE 5 LOW POSITIVE CASES. TWO OF THEM WERE RUN WITH BOTH ORIGINAL BUFFER TUBE AND ORIGINAL SPECIMENS. 5 OF THEM WERE RUN WITH THE ORIGINAL SPECIMEN ONLY. ALL OF THE 7 TESTS WERE NEGATIVE AND THESE MEANS THEY ARE FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921903 KIT BD MAX ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443985 1033573 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1