BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL CHEMISTRY INSTRUMENT

    MDR report key: 730736 · Received June 27, 2006

    Report

    Report Number
    730736
    Event Type
    Malfunction
    Date Received
    June 27, 2006
    Date of Event
    June 20, 2006
    Report Date
    June 27, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    RXL CHEMISTRY INSTRUMENT REPORTED CRITICAL RESULTS OF NA 122, K 2.7 AND CHL 90. INSTRUMENT REPEATED SINCE VALUES WERE CRITICAL. REPEAT RESULTS WERE NA 135, K 3.1 AND CHL 103. DADE COULD NOT EXPLAIN THIS ERROR EXCEPT THEIR USUAL SPECIMEN INTEGRITY. THE INSTRUMENT REPORTED THREE INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION RXL CHEMISTRY INSTRUMENT ANALYZER, CHEMISTRY JJE DADE BEHRING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR