BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH SENSITIVITY TROPONIN I

    MDR report key: 9309187 · Received November 12, 2019

    Report

    Report Number
    2122870-2019-01138
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590318796
    PMA / PMN Number
    K121790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS HSTNI REAGENT WAS NOT RETURNED FOR EVALUATION. THE DATA SUBMITTED BY THE CUSTOMER TO BECKMAN COULTER FOR INVESTIGATION SUPPORTS EVIDENCE OF REPEATABLE ERRONEOUSLY ELEVATED HSTNI PATIENT RESULT OBTAINED ON ACCESS2 ANALYZER S/N 800224: THE ORIGINAL RESULT WAS 55 NG/L AND DUPLICATE RESULTS OF UNCENTRIFUGED SAMPLE WERE RESPECTIVELY 26.7 AND 35.5 NG/L. IT IS ALSO REPORTED ELEVATED HSTNI RESULTS ON DXI ABOUT 27.1 AND 27 NG/L. THE SAMPLE WAS COLLECTED IN A SERUM TUBE, IT WAS FULL AND CLEAR. CALIBRATION PASSED ON (B)(6) 2019 WITH REAGENT LOT 832524 AND CALIBRATOR LOT 832156. SYSTEM CHECK PASSED ON (B)(6) 2019. QC WERE PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CAUSE OF THIS EVENT IS UNKNOWN. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS ELEVATED TROPONIN I (ACCESS HSTNI) PATIENT RESULTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM ACCESS CLINICAL SYSTEM (SERIAL NUMBER (B)(4)). RESULTS WERE DISCORDANT WITH THE ABBOTT I-STAT CTNI METHOD AND THE PATIENT CLINICAL FILE. CALIBRATION, QC (QUALITY CONTROL) AND SYSTEM CHECK WERE WITHIN SYSTEM AND ASSAY SPECIFICATIONS. ADDITIONAL INFORMATION ON THE PATIENT¿S DEMOGRAPHICS SUCH AS AGE OR DATE OF BIRTH WAS NOT SUPPLIED. THERE WAS A CHANGE IN PATIENT TREATMENT BASED ON THE ERRONEOUSLY ELEVATED HSTNI RESULT. PATIENT GIVEN THE FOLLOWING MEDICATION BASED ON INITIAL TROPONIN RESULT AT (B)(6) 2019: LOADING DOSE TICAGRELOR 180MG, ENOXAPARIN 70MG, STAT THERAPEUTIC CLEXANE 1MG/KG. NO FURTHER DOSES GIVEN ACCORDING TO PATIENT CHART. THE PATIENT WAS DISCHARGED AFTER RECEIVING CORRECT RESULT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104269 HIGH SENSITIVITY TROPONIN I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER HIGH SENSITIVITY TROPONIN I 832186 15099590318796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other