BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIMENSION R L CHEMISTRY ANALYZER

    MDR report key: 512799 · Received February 25, 2004

    Report

    Report Number
    512799
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    November 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JJC
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A DADE BEHRING RXL CHEMISTRY GAVE CLINICALLY SIGNIFICANT INCORRECT RESULTS FOR TROPONIN I. THE RESULT WAS 0.46 (NORMAL VALUE IS 0.00-0.34). THE TEST WAS RERUN PRIOR TO RELEASE. THE REPEAT RESULT WAS 0.16. THE INCORRECT VALUE WAS NOT RELEASED AND DID NOT AFFECT PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION R L CHEMISTRY ANALYZER CHEMISTRY ANALYZER JJC DADE BEHRING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other