BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1017769 · Received May 31, 2007

    Report

    Report Number
    1823260-2007-04686
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 31, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL ALKALINE PHOSPHOTASE RESULT OF 240 U/L. SAME SAMPLE REPEATED THREE TIMES GAVE RESULTS OF 516 U/L, 266 U/L AND 240 U/L. THE SAMPLE WAS THEN REPEATED AN ADDITIONAL 5 TIMES AND RECOVERED 234, 228, 233, 225, AND 231 U/L. THE INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP VERIFIED INSTRUMENT PERFORMANCE AND DETERMINED THE CAUSE TO BE PRE-ANALYTICAL. THE USER WAS INSTRUCTED TO FOLLOW MFR'S INSTRUCTIONS FOR SAMPLE HANDLING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA