BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1760820 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06066
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO SAMPLES WITH DISCREPANT ALKALINE PHOSPHOTASE RESULTS. SAMPLE 1, INITIAL RESULT 134 U/L. SAME SAMPLE REPEATED MULTIPLE TIMES GAVE RESULTS OF 32, 27, 27 U/L. SAMPLE 2, INITIAL RESULT 157 U/L. SAME SAMPLE REPEATED MULTIPLE TIMES GAVE RESULTS OF 119, 95, AND 96 U/L. THE INITIAL RESULTS WERE NOT REPORTED. THE USER PERFORMED MAINTENANCE AND TROUBLESHOOTING ACTIVITIES WHICH RESOLVED THE ISSUE.

    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 NA