BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1000691 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01602
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 19, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT RESULTS FOR AST. INITIAL RESULT GAVE <0 U.L; REPEATED TWICE GIVING 13 AND 14 U/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK