BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN ACCESS

    MDR report key: 477161 · Received August 6, 2003

    Report

    Report Number
    MW1029218
    Event Type
    Injury
    Date Received
    August 6, 2003
    Date of Event
    June 25, 2003
    Report Date
    July 25, 2003
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT SEEN INITIALLY IN 2003 FOR INTERMITTENT CHEST PAIN LASTING 3-4 DAYS. EKG-SINUS TECH, CXR-NL TOX SCREEN-NKG. PT ADMITTED WITH TROPONIN LEVEL 3.14 CK 138 CKMB 3. CARDIAC CATH RECOMMENDED, PT DECLINED. STRESS TEST PERFORMED WITH "SMALL ABNORMALITY". PT PRESENTS TO CARDIOLOGIST 2 MONTHS LATER WITH CHEST PAIN. TROPONIN ORDERED 2.38 SENT TO HOSPITAL FOR CARDIAC CATH. REPEAT TROPONIN NEGATIVE AT HOSPITAL, (METHOD: DIMENSION). PT UNDERWENT CARDIAC CATH: NORMAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. 81600 REAGENT LOT 315614

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| O