BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM

    MDR report key: 1032948 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03455
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT RESULTS FOR MULTIPLE ASSAYS. INITIAL TOTAL PROTEIN GAVE 8.9 G/DL; REPEAT GAVE 7.3 G/DL. INITIAL ALBUMIN GAVE 5.9 G/DL; REPEAT GAVE 4.9 G/DL. INITIAL CALCIUM GAVE 11.2 MG/DL, REPEAT GAVE 9.7 MG/DL. INITIAL BICARBONATE GAVE 39 MMOL/L; REPEAT GAVE 29 MMOL/L AND INITIAL GLUCOSE GAVE 156 MG/DL; REPEAT GAVE 115 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE EXACT ROOT CAUSE. 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