BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1001785 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01696
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING SPORADIC HIGH POTASSIUM RESULTS THAT DO NOT FIT THE CLINICAL PICTURE OF THE PT. ONLY THE FOLLOWING EXAMPLE WAS PROVIDED. INITIAL POTASSIUM PLASMA SAMPLE RESULT OF 6.06 MMOL/L, REPEAT 5.92 MMOL/L. A SERUM SAMPLE FROM THE SAME PT DRAWN AT THE SAME TIME GAVE A RESULT OF 4.81 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION. THE USER INDICATED THERE IS EVIDENCE OF A POTENTIAL PRE-ANALYTICAL PROBLEM AT THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK