BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1012734 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02374
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING ERRATIC CALCIUM RECOVERY. THE FOLLOWING PT EXAMPLES WERE PROVIDED. PT 1, INITIAL GAVE 1.7 MG/DL; REPEAT GAVE 9.4 MG/DL. PT 2, INITIAL GAVE 2.5 MG/DL; REPEAT GAVE 9.5 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE CONTAMINATION IN THE FLUIDICS SYSTEM, AND DECONTAMINATED THE WATER SYSTEM AND REPLACED F4 AND DEGASSER FILTERS. PERFORMANCE TESTS WERE PERFORMED.

    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