BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3

    MDR report key: 12001767 · Received June 15, 2021

    Report

    Report Number
    2122870-2021-00085
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: THE FULL PATIENT IDENTIFIER FOR THIS EVENT IS (B)(6). AGE OR DATE OF BIRTH, SEX, WEIGHT, AND ETHNICITY: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. DEVICE EVALUATED BY MFR: THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. OVERALL SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ON (B)(6) 2021, WITH GUIDANCE FROM BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT, CUSTOMER PERFORMED A 30-REPLICATE PRECISION STUDY; TOTAL PRECISION RECOVERY WAS WITHIN ASSAY SPECIFICATIONS. IN CONCLUSION, THE LIKELY CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ERRONEOUS ELEVATED TROPONIN I (ACCUTNI+3 FOR USE ON DXI, PART NUMBER A98264, AND LOT NUMBER 922912) RESULTS, GENERATED ON THE CUSTOMER'S DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC DATES OR SAMPLE RECOVERY DETAILS FOR THOSE PATIENT RESULTS. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER THE PATIENTS WERE HELD LONGER IN THE HOSPITAL FOR MONITORING AND TESTING; THE CUSTOMER ALSO REPORTED THE PATIENTS WERE ADMITTED TO BE TREATED FOR MYOCARDIAL INFARCTION (MI). THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC DETAILS REGARDING TREATMENT PROVIDED TO PATIENTS. THE CUSTOMER DID CONFIRM NO DEATH OR INJURY OCCURRED IN CONNECTION WITH THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. ALTHOUGH THE CUSTOMER DATA INCLUDED A SYSTEM CHECK WHICH FAILED THE UNWASHED PORTION, REPEATING THE SYSTEM CHECK WITH FRESH SYSTEM CHECK SOLUTION YIELDED A PASSING SYSTEM CHECK. OVERALL, SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL RESULTS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA SEPARATOR TUBES, EITHER 13X75 OR 13X100 TUBE SIZE, AND CENTRIFUGED FOR 5600 RPM AT ROOM TEMPERATURE. SAMPLES WERE RUN IN PRIMARY TUBES. NO OTHER SAMPLE PROCESSING OR HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900565 ACCESS ACCUTNI+3 IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922912 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other