BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 11681384 · Received April 16, 2021

    Report

    Report Number
    2122870-2021-00047
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL IDENTIFIER IS CASE(B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INFORMATION SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. THE CUSTOMER NOTED THE LABORATORY HAS OBSERVED PROBLEMS WITH SAMPLES CONTAINING FIBRIN. THE LIKELY CAUSE OF THIS EVENT IS USE ERROR. THE CUSTOMER WAS TESTING SAMPLES WHICH CONTAIN FIBRIN. PER ACCESS ACCUTNI+3 INSTRUCTIONS FOR USE, B16316 H ¿REMOVE ANY RESIDUAL FIBRIN OR CELLULAR MATTER. FAILURE TO DO SO CAN CONTRIBUTE TO FALSELY ELEVATED RESULTS.¿ THERE IS NO EVIDENCE TO REASONABLY SUGGEST AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    ON 08APR2021 THE CUSTOMER REPORTED A NON-REPRODUCIBLE ELEVATED TROPONIN I RESULT (ACCESS ACCUTNI +3 ASSAY, PART NUMBER A98264 AND LOT NUMBER 922912) WERE GENERATED ON THE CUSTOMER'S DXI 600 (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A71460 AND SERIAL NUMBER (B)(4)) ON 06APR2021. THE CUSTOMER DID NOT PROVIDE SPECIFIC RESULT OBTAINED BUT STATED THE RESULT, ABOVE CUSTOMER UPPER REFERENCE LIMIT (URL) OF <0.04 NG/ML, WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPORTED A CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED ONE PATIENT WAS ADMITTED AND RECEIVED A CHEST CT SCAN WITH DYE, X-RAYS AND AN EKG. THE PATIENT WAS RELEASED AFTER CORRECTED TROPONIN I RESULTS WERE OBTAINED. SPECIFIC DETAILS REGARDING TROPONIN I, CT, X-RAY AND EKG RESULTS WERE NOT PROVIDED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE WAS A LITHIUM HEPARIN PLASMA SAMPLE AND PROCESSED USING CUSTOMER'S AUTOMATION LINE. CENTRIFUGATION CONDITIONS WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER NOTED THE LABORATORY HAS OBSERVED PROBLEMS WITH SAMPLES CONTAINING FIBRIN. NO OTHER SAMPLE COLLECTION OR PROCESSING INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578572 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922912 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other