BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CDIFF

    MDR report key: 16542308 · Received March 14, 2023

    Report

    Report Number
    1119779-2023-00283
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    March 3, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OZN
    PMA / PMN Number
    K130470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CDIFF EU (REF. 442555) LOT 2151504 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX CDIFF EU INDICATED THAT LOT 2151504 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT POSITIVE RESULTS OBTAINED FOR EXTERNAL QUALITY CONTROL (LANE B3 IN RUN 5917) AND FOR A PATIENT SAMPLE (LANE A1 IN RUN 6533). ACCORDING TO THE COMPLAINT TEXT, THE EXTERNAL QUALITY CONTROL IS A KNOWN NEGATIVE CONTROL AND THE PATIENT SAMPLE HAD PREVIOUSLY TESTED NEGATIVE IN CULTURE AND WITH THE BD MAX¿ CDIFF TEST ON THE CULTURE SAMPLE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS THESE TWO SAMPLES. ANALYSIS OF THE PCR CURVE SHOWS LATE AND LOW BUT TRUE AMPLIFICATION WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO PRESENCE OF NON-VIABLES CELLS IN THE PATIENT SAMPLE OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE/CONTROL PREPARATION AT THE CUSTOMER¿S SITE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE INVESTIGATION PERFORMED, NO REAGENT 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 CDIFF EU LOT 2151504. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, PRESENCE OF NON-VIABLES CELLS IN THE PATIENT SAMPLE, OR ENVIRONMENTAL OR CROSS CONTAMINATION DURING CONTROL/SAMPLE PREPARATION CAN EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME SINCE NO TRENDS WAS IDENTIFIED. BD LIFE SCIENCES QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: (B)(6). 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

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ CDIFF THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULT FOR TOXIGENIC CLOSTRIDIUM DIFFICILE FROM AN EXTERNAL QUALITY CONTROL. IN THE RUN 5917 ON MX0057, SAMPLE B3 IS INTERPRETED AS POSITIVE BY BD MAX: LOW FLUORESCENCE AND HIGH CT VALUE. HOWEVER, THIS IS A QUALITY CONTROL WITH A KNOWN NEGATIVE RESULT. CUSTOMER ALSO REPORTS A FALSE POSITIVE RESULT FOR CLOSTRIDIUM DIFFICILE ON BD MAX CT0340: RUN 6533, SAMPLE A1. SIMILARLY, THIS SAMPLE WAS CHECKED AS NEGATIVE (CULTURE, THEN BD MAX TEST FROM THE CULTURE), WHEN IT IS MADE POSITIVE IN RUN 6533 (LOW FLUORESCENCE AND HIGH CT VALUE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ CDIFF THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULT FOR TOXIGENIC CLOSTRIDIUM DIFFICILE FROM AN EXTERNAL QUALITY CONTROL. IN THE RUN 5917 ON MX0057, SAMPLE B3 IS INTERPRETED AS POSITIVE BY BD MAX: LOW FLUORESCENCE AND HIGH CT VALUE. HOWEVER, THIS IS A QUALITY CONTROL WITH A KNOWN NEGATIVE RESULT. CUSTOMER ALSO REPORTS A FALSE POSITIVE RESULT FOR CLOSTRIDIUM DIFFICILE ON BD MAX CT0340: RUN 6533, SAMPLE A1. SIMILARLY, THIS SAMPLE WAS CHECKED AS NEGATIVE (CULTURE, THEN BD MAX TEST FROM THE CULTURE), WHEN IT IS MADE POSITIVE IN RUN 6533 (LOW FLUORESCENCE AND HIGH CT VALUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051082 BD MAX¿ CDIFF NA OZN BECTON, DICKINSON & CO. (SPARKS) 2151504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown