BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CDIFF

    MDR report key: 22073936 · Received May 22, 2025

    Report

    Report Number
    3007420875-2025-00078
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 16, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OZN
    UDI-DI
    00382904425555
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E.1. INITIAL REPORTER PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR POSITIVE SAMPLE WITH WEAK AND JAGGED CURVES WHEN USING THE BD MAX¿ CDIFF EU ASSAY (REF. (B)(4)) LOT 4233911 WAS PERFORMED BY THE REVIEW OF THE 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 4233911 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED UNEXPECTED RESULTS WHEN USING THE BD MAX¿ CDIFF ASSAY AND PROVIDED TWO RUN FILES (#10605 AND #10614) AND THE DATABASE FROM INSTRUMENT (B)(6) FOR THE INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS TWO POSITIVE SAMPLES IN POSITION B7 IN RUN 10605 AND A9 IN RUN 10614. PCR CURVES ANALYSIS OF BOTH SAMPLES REVEALED STEP DISLOCATIONS IN THE FAM CHANNEL (CDIFF TARGET) RESULTING IN A POSITIVE RESULT FOR THE CDIFF TARGET FOR BOTH SAMPLES. IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR AN ABERRANT CURVE GEOMETRY 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 CDIFF EU LOT 4233911. THE ROOT CAUSE WAS NOT IDENTIFIED. 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 TREND WAS IDENTIFIED. 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 DURING USE OF BD MAX¿ CDIFF, A FALSE POSITIVE PATIENT RESULT WITH UNUSUAL PCR CURVES WAS OBTAINED. TEST WAS REPEATED ON BD MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ CDIFF, A FALSE POSITIVE PATIENT RESULT WITH UNUSUAL PCR CURVES WAS OBTAINED. TEST WAS REPEATED ON BD MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513839 BD MAX¿ CDIFF C.DIFFICILE TOXIN GENE AMPLIFICATION ASSAY OZN GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233911 00382904425555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown