BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 15312011 · Received August 29, 2022

    Report

    Report Number
    3007420875-2022-00047
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 18, 2022
    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
    PA, 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

    H.6 INVESTIGATION SUMMARY: REVIEW OF THE MANUFACTURING RECORDS OF BOTH BD MAX ENTERIC BACTERIAL PANEL LOT 2102283 AND BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL LOT 2119123 KITS INDICATED THAT LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE FIRST SAMPLE (RUN #5079, POSITION B2) INITIALLY GAVE A POSITIVE RESULT FOR BOTH THE SALMONELLA AND VIBRIO TARGETS BUT WHEN REPEATED, IT GAVE A POSITIVE RESULT FOR THE SALMONELLA TARGET ONLY. THE SECOND SAMPLE (RUN #5085, POSITION B6) INITIALLY GAVE A POSITIVE RESULT FOR THE PLESIOMONAS TARGET BUT WHEN REPEATED, IT WAS NEGATIVE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THESE TWO SAMPLES. ANALYSIS OF PCR CURVES FOR THE FIRST SAMPLE (B2 IN RUN 5079) SHOW EARLY AND TRUE AMPLIFICATION OF THE SALMONELLA TARGET. HOWEVER, THE PCR CURVE OBTAINED FOR THE VIBRIO TARGET SHOWED A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED A VIBRIO POSITIVE RESULT. IT IS UNLIKELY THAT THIS POSITIVE RESULT IS DUE TO TRUE AMPLIFICATION. ANALYSIS OF PCR CURVES FOR SAMPLE B6 IN RUN 5085 ALSO SHOW A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED A PLESIO POSITIVE RESULT. AGAIN, IT IS UNLIKELY THAT THIS POSITIVE RESULT IS DUE TO TRUE AMPLIFICATION. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVES IS A CONSERVATIVE ASSESSMENT. 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 2119123. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THERE WAS DISCREPANT RESULTS. THE CUSTOMER GOT A DOUBLE POSITIVE FOR SALMONELLA AND VIBRIO AND ON REPEAT SALMONELLA WAS POSITIVE AND VIBRIO WAS NEGATIVE. CUSTOMER ALSO GOT A POSITIVE RESULT FOR PLESIOMONAS AND ON REPEAT IT WAS NEGATIVE. THE CUSTOMER REPORTED THE FIRST RUNS RESULTS BUT CORRECTED THE REPORTS AFTER THE REPEATS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX 443812 DISCREPANT RESULTS ON (B)(6) 2022, CUSTOMER GOT A DOUBLE POS - FOR SALMONELLA AND VIBRIO; ON REPEAT - SALMONELLA WAS POS, AND VIBRIO WAS A NEG; ON (B)(6) 2022, CUSTOMER GOT A POS FOR PLESIOMONAS; ON REPEAT, IT WAS A NEG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THERE WAS DISCREPANT RESULTS. THE CUSTOMER GOT A DOUBLE POSITIVE FOR SALMONELLA AND VIBRIO AND ON REPEAT SALMONELLA WAS POSITIVE AND VIBRIO WAS NEGATIVE. CUSTOMER ALSO GOT A POSITIVE RESULT FOR PLESIOMONAS AND ON REPEAT IT WAS NEGATIVE. THE CUSTOMER REPORTED THE FIRST RUNS RESULTS BUT CORRECTED THE REPORTS AFTER THE REPEATS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX 443812 DISCREPANT RESULTS ON (B)(6) 22, CUSTOMER GOT A DOUBLE POS - FOR SALMONELLA AND VIBRIO; ON REPEAT - SALMONELLA WAS POS, AND VIBRIO WAS A NEG; ON (B)(6) 22, CUSTOMER GOT A POS FOR PLESIOMONAS; ON REPEAT, IT WAS A NEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343668 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443812 2119123 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown