BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 18274224 · Received December 6, 2023

    Report

    Report Number
    3007420875-2023-00110
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    September 8, 2023
    Report Date
    December 7, 2023
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D.4. MEDICAL DEVICE LOT #: 3171017 D.4. MEDICAL DEVICE EXPIRATION DATE: 01/04/2025 H.4. MEDICAL DEVICE MANUFACTURING DATE: 07/11/2023 H.6. INVESTIGATION SUMMARY: THE INVESTIGATION FOR THE CUSTOMER COMPLAINT OF FALSE POSITIVE RESULTS WITH BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (XEBP) (REF. 443812) LOTS 2129357 AND 3171017 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOTS 2129357 AND 3171017 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. PCR CURVES OF POSITIVE SAMPLES IN RUNS 1127 AND 1130 SHOW LATE AND LOW, BUT TRUE AMPLIFICATION, FOR YERSINIA (RUN 1127, POSITION A6) AND ETEC (RUN 1130, POSITIONS A1 AND A2) TARGETS WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL TITERS 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. PCR CURVES OF TWO OTHER POSITIVE VIBRIO RESULTS FOUND (SAMPLES A1 AND A2 IN RUN 1130), REVEALED STRONG POSITIVE AMPLIFICATIONS WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL PCR CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, TRUE POSITIVE RESULTS, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE POTENTIAL CAUSES TO EXPLAIN CUSTOMER¿S POSITIVE RESULTS. NONETHELESS, NO REAGENTS ISSUE IS 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 LOTS 2129357 AND 3171017. 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 SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT/EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H.3. 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

    ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT SAMPLES IN KIT BD MAX EXT ENTERIC BACTERIAL PANEL GAVE FALSE POSITIVE RESULTS: RUN # XEBP LOT POS RESULTS ANALYSIS 1130 3171017 A2 ETEC POS LATE LOW.

    Description of Event or Problem · 0

    3 OF 5 IT WAS REPORTED THAT SAMPLES IN KIT BD MAX EXT ENTERIC BACTERIAL PANEL GAVE FALSE POSITIVE RESULTS: RUN 1130, A2 NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885587 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3171017 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown