BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM

    MDR report key: 1041307 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03902
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT BICARBONATE RESULTS. INITIAL RESULT GAVE 41 MMOL/L; REPEATED GAVE 31 MMOL/L. INITIAL RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED ROOT CAUSE TO BE DUE TO A BLOCKED SAMPLE PROBE AND REPLACED AND ADJUSTED SAMPLE PROBE AND FLUSHED OUT RINSE NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 917 DISK SYSTEM CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK