BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1052720 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04297
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT BICARBONATE RESULTS. RESULTS NOT REPORTED, PATIENTS NOT ADVERSELY AFFECTED. PATIENT 1 INITIAL RESULT -230 MMOL/L, REPEATED AROUND 20 MMOL/L. PATIENT 2 INITIAL RESULT -230 MMOL/L, REPEAT RESULT NOT PROVIDED. FIELD SERVICE REPRESENTATIVE DETERMINED ROOT CAUSE TO BE LOW PRESSURE AT THE PRESSURE CONTAINER. THE PRESSURE CONTROL VALVE WAS ADJUSTED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK