BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 15553828 · Received October 6, 2022

    Report

    Report Number
    3007420875-2022-00064
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 2, 2022
    Report Date
    December 1, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT CONCERNS SEVEN PATIENT SAMPLES TESTED DURING THE LAST THREE WEEKS THAT WERE NEGATIVE FOR THE SALMONELLA TARGET WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL (442963) KIT LOT 2110901 BUT WERE POSITIVE IN CULTURE. COMPLAINT HISTORY REVIEW SHOWED ONE OTHER COMPLAINT ON THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 2110901 FOR FALSE NEGATIVE RESULT OF A DIFFERENT TARGET (STX TARGET), STILL UNDER INVESTIGATION. IN THE LAST TWELVE MONTHS, THREE OTHER COMPLAINTS WERE FILED ON BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY FOR FALSE NEGATIVE RESULTS. FOR ONE OF THOSE COMPLAINTS, NO CAUSE WAS IDENTIFIED, FOR ANOTHER EXTERNAL CONTROL PREPARATION/SAMPLE AT ASSAY LOD WAS SUSPECTED AND THE THIRD IS STILL IN INVESTIGATION (SAME KIT LOT). BASED ON THE COMPLAINT REVIEW, NO REAGENTS ISSUE WAS IDENTIFIED. NO ANOMALY WAS OBSERVED, IN BHR REVIEW OF BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 2110901 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, THE KIT MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. TWELVE REACTIONS FROM THE RETAIN MATERIAL OF BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 2110901 WERE VISUALLY INSPECTED AND TESTED IN POSITIVE, WITH EBP TARGETS. ALL THE RESULTS WERE POSITIVE, AS EXPECTED, AND NO PERFORMANCE ISSUE WAS OBSERVED. NO SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER IDENTIFIED SEVEN PATIENT SAMPLES DURING THE LAST THREE WEEKS BEING NEGATIVE FOR THE SALMONELLA TARGET BUT POSITIVE IN CULTURE. MANUAL PCR CURVE ADJUDICATION OF THE SEVEN NEGATIVE RESULTS REVEALED GOOD AMPLIFICATION OF THE SPC WITHOUT ANOMALY, WITHOUT AMPLIFICATION FOR THE SALMONELLA TARGET (FLAT CURVES IN THE VIC CHANNEL). AMONG ALL THE RESULTS IN THE RUNS RECEIVED, ONE POSITIVE CONTROL AS WELL AS FOUR PATIENT SAMPLES OBTAINED POSITIVE RESULTS FOR THE SALMONELLA TARGET, USING KIT LOT 2110901 INVOLVED IN THE CURRENT COMPLAINT. THE POSITIVE CONTROL SHOWS STRONG AMPLIFICATION AND ALL THE POSITIVE PATIENT SAMPLES SHOW AMPLIFICATION WITHOUT ANOMALY. THESE RESULTS SUGGEST THAT THE KIT LOT 2110901 IS ABLE TO FUNCTION PROPERLY FOR POSITIVE CONTROLS AND POSITIVE PATIENT SAMPLES. NEVERTHELESS, MANUAL 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, SPECIMENS CONTAINING UNDETECTED STRAINS OF SALMONELLA, OR AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) ARE POSSIBLE CAUSES OF THE DISCREPANT RESULTS. BUT, IT IS ALSO POSSIBLE THAT ALL THE NEGATIVE RESULTS WERE TRUE NEGATIVE AND THAT DISCREPANT RESULTS WERE CAUSED BY ENVIRONMENTAL OR CROSS CONTAMINATION DURING SAMPLE PREPARATION FOR THE CULTURE. THOSE HYPOTHESES HAVE BEEN IDENTIFIED AS THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. HOWEVER, BD IS UNABLE TO CONFIRM THE CAUSE OF THE CUSTOMER ISSUE, ALTHOUGH NO BD MAX¿ ENTERIC BACTERIAL PANEL REAGENTS ISSUE IS SUSPECTED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE: OOI, PCH, PCI. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THERE HAVE BEEN 7 OCCURRENCES OF PATIENTS WITH RESULTS OF PCR NEGATIVE FOR SALMONELLA BUT ARE POSITIVE IN CULTURE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY PERFORM IN PARALLEL CULTURE AND PCR. THEY FOUND 7 PATIENTS DURING THE LAST 3 WEEKS BEING NEG FOR SALMONELLA PCR BUT POSITIVES IN CULTURE. THEY FOND NOT NORMAL SO MANY CASES. IT COULD HAPPEN ONE A WHILE BUT THIS IS NOW FREQUENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THERE HAVE BEEN 7 OCCURRENCES OF PATIENTS WITH RESULTS OF PCR NEGATIVE FOR SALMONELLA BUT ARE POSITIVE IN CULTURE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY PERFORM IN PARALLEL CULTURE AND PCR. THEY FOUND 7 PATIENTS DURING THE LAST 3 WEEKS BEING NEG FOR SALMONELLA PCR BUT POSITIVES IN CULTURE. THEY FOND NOT NORMAL SO MANY CASES. IT COULD HAPPEN ONE A WHILE BUT THIS IS NOW FREQUENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897310 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 442963 UNKNOWN 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown