BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CDIFF

    MDR report key: 19356430 · Received May 20, 2024

    Report

    Report Number
    3007420875-2024-00048
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    February 20, 2024
    Report Date
    July 26, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OZN
    UDI-DI
    00382904425555
    PMA / PMN Number
    K130470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION BASED ON NEW INFORMATION RECEIVED: B5. REPORT 1 OF 2: IT WAS REPORTED THAT WHILE USING BD MAX¿ CDIFF, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE CLOSTRIDIUM DIFFICILE RESULTS FOR PATIENT SAMPLES. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. B3. DATE OF EVENT: 20-FEB-2024; D4. MEDICAL DEVICE LOT #: 3200294; D4. MEDICAL DEVICE EXPIRATION DATE: 18-JAN-2025; H4. DEVICE MANUFACTURE DATE: 19-JUL-2023; G4. PMA / 510(K)#: NA. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX CDIFF KIT (REF. 442555) LOTS 3200294 AND 3291325 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT FALSE POSITIVE CDIFF RESULTS ON PATIENT SAMPLES AND NEGATIVE CONTROLS OBTAINED WITH BD MAX¿ CDIFF KIT LOTS 3200294 AND 3291325 AND CULTURE FOR ONE PATIENT. SAMPLES REPEATED AS NEGATIVE ON ANOTHER PLATFORM. REVIEW OF MANUFACTURING RECORDS OF THE BD MAX CDIFF INDICATED THAT THE LOTS 3200294 AND 3291325 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED DATABASE FROM INSTRUMENT CT2545. CUSTOMER IDENTIFIED RUNS 1321, 1325, 1333, 1337, 1354, 1360, 1430 AND 1436 AS CONTAINING PROBLEMATIC SAMPLES. MANUAL PCR ADJUDICATION WAS PERFORMED ACROSS 11 SAMPLES IDENTIFIED BY THE CUSTOMER. THE ANALYSIS REVEALED STEP DISLOCATION IN THE RAW PCR SIGNAL OF 6 OUT OF THE 11 SAMPLES LISTED (RUN 1321; POSITION B9, 1325; B1, 1337; B5, 1430; A5, 1436; A2 AND A5). IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS. IT MUST BE NOTED THAT 5 OUT OF THESE 6 SAMPLES WERE TESTED USING PUMP 1 AND WERE POTENTIALLY CAUSED BY AN INSTRUMENT ISSUE AFTER REVIEW BY A BD INSTRUMENT QUALITY ENGINEER. AN INSTRUMENT SERVICE CASE WAS OPENED TO ASSESS A POTENTIAL PUMP 1 ISSUE ON THE INSTRUMENT CT2545. THE CURVES OBTAINED FOR THE REMAINING 5 SAMPLES (RUN 1333; POSITION B1, 1354; B7 AND B11, 1360; A9 AND A11) SHOWED NO ABERRANT GEOMETRY. THE DISCREPANCIES IN RESULTS BETWEEN THE BD MAX¿ CDIFF AND THE OTHER ASSAY USED BY THE CUSTOMER COULD BE DUE TO SAMPLES AT THE ASSAY LIMIT OF DETECTION. DISCREPANCIES BETWEEN THE PLATFORMS CAN ALSO BE EXPLAINED BY THE FACT THAT LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL OR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. WITHOUT ADDITIONAL DATA, BD IS UNABLE TO IDENTIFY THE CAUSE OF THE CUSTOMER ISSUE. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CDIFF LOTS 3200294 OR 3291325. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, AN INSTRUMENT ISSUE, SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) AND LOD VARIABILITY BETWEEN PLATFORMS COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN H3. 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

    REPORT 1 OF 2: IT WAS REPORTED THAT WHILE USING BD MAX¿ CDIFF, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE CLOSTRIDIUM DIFFICILE RESULTS FOR PATIENT SAMPLES. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ CDIFF, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE CLOSTRIDIUM DIFFICILE RESULTS FOR PATIENT SAMPLES. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603403 BD MAX¿ CDIFF C.DIFFICILE TOXIN GENE AMPLIFICATION ASSAY OZN GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3200294 00382904425555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown