BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 12643700 · Received October 15, 2021

    Report

    Report Number
    3007420875-2021-00058
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 23, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904438128
    PMA / PMN Number
    K170308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1033871 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/13/2022 H.4. DEVICE MANUFACTURE DATE: 2/4/2021 H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE KIT BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (XEBP) (REF (B)(4)) LOT 1033871 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. ALTHOUGH NO KIT LOT WAS ORIGINALLY PROVIDED, ANALYSIS OF THE CUSTOMER DATA REVEALED THAT BD MAX¿ XEBP KIT LOT 1033871 WAS USED TO TEST THE SUSPECTED FALSE POSITIVE SAMPLES AND WAS THUS INVESTIGATED IN THIS REPORT. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SUSPECTED YERSINIA FALSE POSITIVE RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (XEBP) ASSAY. ACCORDING TO THE CUSTOMER, SWEDEN HAS A LOW PREVALENCE OF YERSINIA, AND THEY HAVE MORE POSITIVE RESULTS THAN EXPECTED. SOME SAMPLES WITH POSITIVE BD MAX¿ XEBP RESULTS WERE SENT TO OTHER LABORATORIES AND THE RESULTS WERE NEGATIVE. CUSTOMER PROVIDED SEVEN RUNS, A TABLE SHOWING THE POSITIVE YERSINIA RESULTS SINCE MAY 2021 AS WELL AS DATABASE FROM BD MAX¿ INSTRUMENT CT1252 FOR INVESTIGATION. ANALYSIS OF THE YERSINIA POSITIVE RESULTS IN TIME SHOW THAT THE YERSINIA POSITIVITY RATE DECREASED IN TIME AND HAD STABILIZED SINCE MAY 2021. BETWEEN SEPTEMBER 2018 AND APRIL 2021, 864 SAMPLES WERE TESTED, FOR A RATE OF 2.3% YERSINIA POSITIVE RESULTS WHEREAS BETWEEN MAY 2021 AND SEPTEMBER 2021, 2826 SAMPLES WERE TESTED WITH THE ASSAY, FOR A RATE OF 1.2% YERSINIA POSITIVE RESULTS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE RUNS CONTAINING YERSINIA POSITIVE RESULTS SINCE MAY 2021. PCR CURVES ANALYSIS SHOW TRUE AMPLIFICATION IN THE FAM CHANNEL (YERSINIA TARGET) FOR 13 OUT OF THE 15 SAMPLES, WITH CT VALUES BETWEEN 21,4 AND 37,1. IT MUST BE NOTED THAT AMONG THESE 13 SAMPLES, 9 GAVE LATE CT VALUES (CT >30). SUCH LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL LOAD IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. THE TWO OTHER SAMPLES (RUN 259, POSITION B3 AND RUN 297, POSITION B7) SHOW A STEP DISLOCATION IN THE RAW PCR SIGNAL WHICH GENERATED POSITIVE RESULTS. IT IS UNLIKELY THESE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE INFORMATION PROVIDED AND INVESTIGATION RESULTS, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULT, BUT OVERALL, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 1033871. THE ROOT CAUSE WAS NOT IDENTIFIED. 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.

    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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. PCR TESTS WERE USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS POSITIVE YERSINIA RESULTS WITH LATE CT-VALUES AND ALSO ATYPICAL CURVES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. PCR TESTS WERE USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER HAS POSITIVE YERSINIA RESULTS WITH LATE CT-VALUES AND ALSO ATYPICAL CURVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538819 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443812 1033871 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown