BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1052722 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04292
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K91595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 131 MMOL/L; REPEATED TWICE GAVE 140 MMOL/L EACH TIME. INITIAL RESULT WAS NOT REPORTED. CUSTOMER PERFORMED MAINTENANCE AND TROUBLESHOOTING ACTIVITIES WHICH RESOLVED THE ISSUE. CUSTOMER DECLINED FIELD SERVICE DISPATCH.

    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 UNK