BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 12150394 · Received July 12, 2021

    Report

    Report Number
    2122870-2021-00101
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PATIENT IDENTIFIER IS (B)(6). 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. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ADDITIONALLY, A PRECISION RUN PERFORMED ON (B)(6) 2021 MET ASSAY PRECISION SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED ERRONEOUS NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3 FOR USE ON DXI, PART NUMBER A98264 AND LOT NUMBER 922912) WERE GENERATED ON THE CUSTOMER'S DXI 800 (DXI 800 ACCESS IMMUNOASSAY W/DUAL GANTRY, PART NUMBER A71457 AND SERIAL NUMBER (B)(4)) FOR ONE (1) PATIENT. THE INITIAL RESULT WAS 4.51 NG/ML (00:13); THE SAMPLE WAS REPEAT TESTED AND A RESULT OF 0.00 NG/ML (07:36) WAS OBTAINED. THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER REFERENCE RANGE FOR TROPONIN I IS <0.04 NG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED LOVENOX (DOSAGE NOT PROVIDED). THE PATIENT WAS DISCHARGED THE SAME DAY AFTER THE RESULT OF 0.00 NG/ML WAS OBTAINED AT 07:36. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. A PRECISION RUN PERFORMED BY THE CUSTOMER ON (B)(6) 2021 PASSED WITHIN ASSAY SPECIFICATIONS. THE CUSTOMER NOTED THE SAMPLE WAS SLIGHTLY HEMOLYZED. SAMPLE HANDLING INFORMATION SUCH AS SAMPLE TYPE, CENTRIFUGATION TIME, SPEED AND TEMPERATURE AND ALIQUOTTING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046516 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922912 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other