BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 957471 · Received December 3, 2007

    Report

    Report Number
    1823260-2007-10409
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 13, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT 122 MMOL/L. SAME SAMPLE REPEATED THREE TIMES GAVE RESULT OF 130, 130, AND 131 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE DISCREPANCY TO BE A PROBLEM WITH THE SAMPLE PROBES, WHICH HE REPLACED. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR