BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 13177688 · Received January 6, 2022

    Report

    Report Number
    3007420875-2021-00067
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    November 28, 2021
    Report Date
    March 22, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. 442963) LOT 1243582 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND BY THE COMPLAINT¿S HISTORY REVIEW BY THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOT 1243582 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED A HIGH RATE OF POSITIVE RESULTS (SUSPECTED FALSE POSITIVE) WITH BD MAX¿ ENTERIC BACTERIAL PANEL (442963) KIT LOT 1243582, FOR STX AND CAMPY TARGETS. CUSTOMER PROVIDED DATABASES FROM INSTRUMENTS CT1162 AND CT1164 FOR INVESTIGATION. THE CUSTOMER¿S SUSPECTED FALSE POSITIVE RESULTS IN RUN 2275 FROM INSTRUMENT CT1162 WERE IDENTIFIED AS SAMPLES IN POSITIONS A1, A3, A4, A7, A11 AND A12 FOR THE STX TARGET AND POSITIONS A7, A9, A10 AND A11 FOR THE CAMPY TARGET. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE SUSPECTED POSITIVE RESULTS AND A NORMALIZER DRIFT WAS IDENTIFIED IN THE CY5 CHANNEL (STX TARGET) RESULTING IN STX FALSE POSITIVE RESULTS FOR SAMPLES IN POSITIONS A1, A3, A4, A7, A11 AND A12. THIS ISSUE WAS CONFIRMED BY A BD INSTRUMENT QUALITY ENGINEER. AN INSTRUMENT SERVICE TICKET WAS INITIATED AFTER RUN #2275 AND ACCORDING TO THE CUSTOMER THE ISSUE WAS RESOLVED ON 2021-12-20. REGARDING CAMPY POSITIVE SAMPLES (POSITIONS A7, A9, A10 AND A11), CURVES ANALYSIS SHOWED LATE AND LOW BUT TRUE FLUORESCENCE DETECTION THAT CROSSED THE THRESHOLD AND GAVE A POSITIVE RESULT FOR ALL FOUR SAMPLES, IN THE CORRESPONDING CHANNEL (FAM). NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. ALL THE SAMPLES ACCESSION ID WERE FOUND ON INSTRUMENT CT1164 DATABASE IN RUN 2095 AT POSITIONS A1, A3, A4, A6, A6, A7, A9, A10, A11 AND A12 RESPECTIVELY. ALL THE SAMPLES HAD NEGATIVE RESULTS UPON REPEAT TEST. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS FOR THE CAMPY TARGET (RUN 2275 POSITIONS A7, A9, A10 AND A11). FURTHERMORE, A NORMALIZATION DRIFT ISSUE (RESOLVED FOLLOWING AN INSTRUMENT SERVICE TICKET) CAUSED THE FALSE POSITIVE RESULTS FOR THE STX TARGET (RUN 2275 POSITIONS A2, A3, A4, A7, A11 AND A12). OVERALL, BASED ON INVESTIGATION RESULTS, NO REAGENTS ISSUE IS SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED FOR THE CAMPY FALSE POSITIVE RESULT; HOWEVER, A NORMALIZATION DRIFT ISSUE (NOW RESOLVED) WAS THE CAUSE OF THE POSITIVE STX TARGET RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOT 1243582. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL 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: " HIGH RATE OF POSITIVE TARGET. CUSTOMER IS ALLEGING FALSE POSITIVE RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL 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: "HIGH RATE OF POSITIVE TARGET. CUSTOMER IS ALLEGING FALSE POSITIVE RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666392 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL PCI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 442963 1243582 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown