BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1006899 · Received February 26, 2008

    Report

    Report Number
    1823260-2008-01841
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 26, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT RESULTS FOR MULTIPLE TESTS. UNITS OF MEASURE NOT PROVIDED. SAMPLE 1, INITIAL AIK RESULT -5; REPEAT 167. INITIAL CRP RESULT 0.0; REPEAT 50.3. INITIAL GGT RESULT 3; REPEAT 265. INITIAL ALT RESULT 0; REPEAT 71. INITIAL AST RESULT 6; REPEAT 46. SAMPLE 2, INITIAL CRP RESULT 0.0; REPEAT 134.3. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IN ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS COBAS CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK