BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 161990 · Received April 8, 1998

    Report

    Report Number
    1628664-1998-00027
    Event Type
    Injury
    Date Received
    April 8, 1998
    Date of Event
    March 13, 1998
    Report Date
    April 6, 1998
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 03/13/1998 THE ACCOUNT REPORTED ERRATIC CK-MB AND TROPONIN RESULTS AND THE PATIENT SUBSEQUENTLY HAD A CARDIAC CATHERIZATION. A CK-MB RESULT OF 23.2 N/ML AND A TROPONIN RESULT OF 14.7 NG/ML WERE REPORTED. THE SAMPLE WAS LATER RETESTED AND GAVE THE FOLLOWING RESULTS: CK-MB= 3.9 NG/ML AND TROPONIN= 0.1 NG/ML. THE ACCOUNT STATED THE SERUM SAMPLE WAS FOUND CLOTTED. THE PATIENT HAS BEEN DISCHARGED. NO FURTHER INFO HAS BEEN PROVIDED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MFG., INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other AXSYM TROPONIN REAGENT, LIST NUMBER 3C29-20.| AXSYM CK-MB REAGENT, LIST NUMBER 7A57-20,