BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 19632577 · Received June 28, 2024

    Report

    Report Number
    3007420875-2024-00061
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 28, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904438128
    PMA / PMN Number
    K214122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. (B)(4) LOT 3256328 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT AN INCREASE OF VIBRIO POSITIVE RESULTS ALONG WITH ATYPICAL CURVES OBTAINED WHEN USING THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 3256328 WHILE THEY REPEATED AS POSITIVE IN CULTURE. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOT 3256328 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED DATABASE FOR INSTRUMENT CT1551 AND CT3300 ALONG WITH RUN FILES 122, 124, 125, 126 (FROM CT1551) AND 72 (FROM CT3300) THAT WERE ANALYZED. ON INSTRUMENT CT1551, TWO BD MAX¿ XEBP KIT LOTS WERE USED IN THE LAST YEAR, INCLUDING LOT 3256328, WHICH PRESENTED A VIBRIO POSITIVITY RATE OF 0.5% FOR A TOTAL OF 1477 SAMPLES TESTED WITH THIS LOT SINCE MARCH 2024. ON INSTRUMENT CT3300, FOUR BD MAX¿ XEBP KIT LOTS WERE USED IN THE LAST YEAR. SINCE MARCH 2024, ONLY TWO SAMPLES WERE TESTED WITH KIT LOT 3256328 AND ONE OF THEM WAS POSITIVE FOR THE VIBRIO TARGET. THE ANALYSIS OF THE RESULTS OBTAINED WITH ALL KIT LOTS USED ON INSTRUMENTS CT1551 AND CT3300 REVEALED A TOTAL OF 34 VIBRIO POSITIVE RESULTS USING THE BD MAX¿ XEBP ASSAY. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL THESE POSITIVE RESULTS AND ALL THE RESULTS APPEARED TO BE TRUE AMPLIFICATIONS, WITHOUT ANOMALY. CUSTOMER PROVIDED FIVE RUN FILES WHICH, ACCORDING TO THE COMPLAINT DESCRIPTION, ARE CONTAINING VIBRIO SUSPECTED FALSE POSITIVE SAMPLES ASSOCIATED TO JAGGED CURVES. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THESE SUSPECTED FALSE VIBRIO RESULTS AND ANALYSIS REVEALED THAT THE POSITIVE VIBRIO RESULTS WERE ALL LATE AND LOW, AND APPEARED TO BE TRUE VIBRIO POSITIVE RESULTS. SAMPLE IN RUN 122 (POSITION A8) GAVE A NEGATIVE RESULT UPON REPEAT, BUT AN AMPLIFICATION IN THE ROX CHANNEL (VIBRIO) IS VISIBLE SUGGESTING A CONCENTRATION NEAR THE ASSAY LIMIT OF DETECTION. NO ANOMALY IN THE AMPLIFICATION CURVES (JAGGED CURVE) IS ASSOCIATED WITH THOSE POSITIVE RESULTS. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA BUT BASED ON THE ANALYSIS, NO FALSE POSITIVE RESULTS ARE SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 3256328. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, 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. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED THAT WHEN USING THE KIT BD MAX EXT ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE VIBRIO RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED THAT WHEN USING THE KIT BD MAX EXT ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE VIBRIO RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828862 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3256328 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown