BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Access hsTnI

    MDR report key: 9309192 · Received November 12, 2019

    Report

    Report Number
    2122870-2019-01139
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 12, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    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

    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 (B)(4): THE ORIGINAL RESULT WAS 87 NG/L ON (B)(6) 2019 AND DUPLICATE RESULTS OF UNCENTRIFUGED SAMPLE WERE RESPECTIVELY 3.3 AND 3.5 NG/L ON (B)(6) 2019. THE SAMPLE WAS COLLECTED IN A RAPID SERUM TUBE LOT 190209, 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. (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. INVESTIGATIONS REQUIRED. THERE WAS A CHANGE IN PATIENT TREATMENT BASED ON THE ORIGINAL ERRONEOUSLY ELEVATED HSTNI RESULT. PATIENT TREATED FROM (B)(6) 2019 WITH THE FOLLOWING MEDICATION BASED ON INITIAL TROPONIN RESULT AT 15:50 (B)(6) 2019: CLOPIDOGREL 300 MG LOADING DOSE + 3 DOSES OF 75 MG. ASPIRIN 300 MG LOADING DOSE + 3 DOSES OF 100 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104421 Access hsTnI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER ACCESS HSTNI 2X50 DET 832524 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other