BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 20272283 · Received September 20, 2024

    Report

    Report Number
    3007420875-2024-00085
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    July 6, 2024
    Report Date
    November 1, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. 443812) LOTS 4030731, 4051425 AND 4080024 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT SEVEN DISCREPANT RESULTS THAT TESTED POSITIVE WHEN USING BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOTS 4030731, 4051425 OR 4080024 BUT WERE TESTED NEGATIVE BY AN EXTERNAL LABORATORY. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOTS 4030731, 4051425 AND 4080024 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN FILES 87, 144, 185, 194, 201 AND 208 FROM INSTRUMENT CT3207 FOR INVESTIGATION. CUSTOMER DESIGNATED AS TO INVESTIGATE THE POSITIVE RESULTS THAT WERE OBTAINED FOR ETEC IN RUN 87; POSITION B9 (TESTED WITH KIT LOT 4030731), 144; A6 (TESTED WITH KIT LOT 4051425), 185; B3, 194; A3 AND 208; B4 (TESTED WITH KIT LOT 4080024), AND FOR VIBRIO IN RUN 201; POSITIONS A3 AND A5 (TESTED WITH KIT LOT 4080024). THEY ALL CAME BACK NEGATIVE WHEN TESTED BY AN EXTERNAL LABORATORY. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL THE POSITIVE SAMPLES INDICATED BY THE CLIENT IN THE COMPLAINT TEXT. SAMPLES IN RUN 87; POSITION B9, 144; A6, 185; B3 AND 194; A3 ALL SHOW LATE OR LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR ETEC. SAMPLE IN RUN 208; POSITION B4 SHOWS A STRONG POSITIVE RESULT FOR ETEC. SAMPLES IN RUN 201; POSITIONS A3 AND A5 SHOWS LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR VIBRIO. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA BUT BASED ON THE ANALYSIS. THE SAMPLES THAT SHOW LATE RESULTS SUGGEST SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION DURING SAMPLE PREPARATION. THE POSITIVE SAMPLE IN RUN 208 DISPLAYS A STRONG POSITIVE AMPLIFICATION INDICATING A TRUE POSITIVE RESULT. THE LATE POSITIVE RESULTS COULD EXPLAIN THE DISCREPANCY WITH THE REFERENCE LABORATORY. IT MUST BE NOTED THAT LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NO INFORMATION WAS PROVIDED ABOUT THE ANALYSIS METHOD USED BY THE EXTERNAL LABORATORY. 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 LOTS 4030731, 4051425 OR 4080024. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, AND VARIATION BETWEEN ASSAYS ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    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.

    Description of Event or Problem · 0

    REPORT 6 OF 7: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT RESULT FOR VIBRIO WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE ILLINOIS DEPT. OF PUBLIC HEALTH (IDPH), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 6 OF 7: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT RESULT FOR VIBRIO WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE ILLINOIS DEPT. OF PUBLIC HEALTH (IDPH), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526052 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4080024 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown