BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 15477201 · Received September 24, 2022

    Report

    Report Number
    3007420875-2022-00054
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 9, 2022
    Report Date
    December 9, 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
    AU
    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: COMPLAINT HISTORY REVIEW REVEALED NO COMPLAINT ON THE BD MAX¿ XEBP KIT LOT: 2045538. SEVERAL OTHER COMPLAINTS FOR FALSE POSITIVE AND DISCREPANT RESULTS WITH THE BD MAX¿ XEBP ASSAY WERE FILED IN THE LAST TWELVE MONTHS, FOR VARIOUS TARGETS, AND A SAMPLE AT THE ASSAY LIMIT OF DETECTION AND CONTAMINATION WERE IDENTIFIED AS POTENTIAL CAUSES. BASED ON THE COMPLAINT REVIEW, NO REAGENTS ISSUE WAS IDENTIFIED. NO ANOMALY WAS OBSERVED, IN BHR REVIEW OF BD MAX¿ XEBP KIT LOT: 2045538 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, ALL FOUR KITS MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. THE RETAIN MATERIAL DID NOT NEED TO BE TESTED SINCE IT WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. A GROSS PRODUCT CONTAMINATION WOULD HAVE BEEN DETECTED BY THE FINAL QC TEST, WHICH IS NOT THE CASE. NO SAMPLE WAS RECEIVED FOR INVESTIGATION. ONE RUN PERFORMED WITH THE BD MAX¿ XEBP ASSAY WAS RECEIVED FOR INVESTIGATION AND ANALYZED WITH BANCS ALGORITHM SIMULATION SOFTWARE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED, SHOWING A STEP DISLOCATION IN THE RAW PCR SIGNAL, RESULTING IN A VIBRIO POSITIVE RESULT FOR SAMPLE IN RUN 520 A10. IT IS UNLIKELY THAT THIS PCR CURVE PATTERN WAS THE RESULT OF TRUE AMPLIFICATION. UNFORTUNATELY, NO ROOT CAUSE COULD BE IDENTIFIED, BUT THE ISSUE SEEMED ISOLATED. BASED ON THE INVESTIGATION, BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE ISSUE. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (XEBP) (REF. 443812) LOT: 2045538 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL LOT: 2045538 KIT INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE POSITIVE RESULTS IN POSITION A10. ANALYSIS OF PCR CURVE A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED A VIBRIO POSITIVE RESULT. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION IN THE ROX CHANNEL AND A ROOT CAUSE COULD NOT BE IDENTIFIED. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVES IS A CONSERVATIVE ASSESSMENT OF THE DATA. 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: 2045538. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. 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 TWO OCCURRENCES OF FALSE POSITIVE RESULTS. PATIENT SAMPLES WERE INVOLVED AND REPORTED TO THE CLINICIAN BUT THERE WAS NO IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN SOME RUNS SINCE JUNE, SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE, BUT NEGATIVE IN THE REPEATS ON BD MAX. DATE RUN LOT ID RESULT REPEAT RESULT CULTURE ON (B)(6) 2022 418, BAS20220609, (B)(6) SALM, STX, SHIG POS, NEGATIVE ON (B)(6) 2022 430, BAS20220620, (B)(6) SHIG, STX POS, NEGATIVE STX POS, ON (B)(6) 2022 455, BAS20220707, (B)(6) SHIG, STX, SALM POS, NEGATIVE ON (B)(6) 2022 500, KAL09082022, (B)(6) SHIG, STX POS, NEGATIVE ON (B)(6) 2022 500, KAL09082022, (B)(6) SHIG, STX, SALM POS, NEGATIVE ON (B)(6) 2022 520, BAS20220824, (B)(6) VIBRIO POS, NEGATIVE ON (B)(6) 2022 520, BAS20220824, (B)(6) VIBRIO POS, NEGATIVE CT2361.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THERE WAS TWO OCCURRENCES OF FALSE POSITIVE RESULTS. PATIENT SAMPLES WERE INVOLVED AND REPORTED TO THE CLINICIAN BUT THERE WAS NO IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN SOME RUNS SINCE ON (B)(6), SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE, BUT NEGATIVE IN THE REPEATS ON BD MAX DATE RUN LOT ID RESULT REPEAT RESULT CULTURE ON (B)(6) 2022 418, BAS20220609, (B)(6) SALM, STX, SHIG POS, NEGATIVE, ON(B)(6) 2022 430, BAS20220620, (B)(6) SHIG, STX POS, NEGATIVE, STX POS, ON (B)(6) 2022 455, BAS20220707, (B)(6) SHIG, STX, SALM POS, NEGATIVE ON (B)(6) 2022 500, KAL09082022, (B)(6) SHIG, STX POS, NEGATIVE ON (B)(6) 2022 500, KAL09082022, (B)(6) SHIG, STX, SALM POS, NEGATIVE ON (B)(6) 2022 520, BAS20220824, (B)(6) VIBRIO POS, NEGATIVE, NEGATIVE, ON (B)(6) 2022 520, BAS20220824, (B)(6) VIBRIO POS, NEGATIVE. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THERE WAS TWO OCCURRENCES OF FALSE POSITIVE RESULTS. PATIENT SAMPLES WERE INVOLVED AND REPORTED TO THE CLINICIAN BUT THERE WAS NO IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN SOME RUNS SINCE ON (B)(6), SALMONELLA, SHIGATOXIN, SHIGELLA AND VIBRIO WERE POSITIVE, BUT NEGATIVE IN THE REPEATS ON BD MAX. DATE RUN LOT ID RESULT REPEAT RESULT CULTURE ON (B)(6) 2022 418, BAS20220609, (B)(4) SALM, STX, SHIG POS, NEGATIVE, ON (B)(6) 2022 430, BAS20220620, (B)(4) SHIG, STX POS, NEGATIVE, STX POS, ON (B)(6) 2022 455, BAS20220707, (B)(4) SHIG, STX, SALM POS, NEGATIVE, ON (B)(6) 2022 500, KAL09082022, (B)(4) SHIG, STX POS, NEGATIVE, ON (B)(6) 2022 500, KAL09082022, (B)(4) SHIG, STX, SALM POS, NEGATIVE, ON (B)(6) 2022 520, BAS20220824, (B)(4) VIBRIO POS, NEGATIVE, NEGATIVE, ON (B)(6) 2022 520, BAS20220824, (B)(4) VIBRIO POS, NEGATIVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123939 KIT BD MAX EXT ENTERIC BACTERIAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443812 UNKNOWN 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown