BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1030439 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03329
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCED LOW PATIENT SODIUM RESULTS FOR SIXTY PT SAMPLES. ALTHOUGH NO ACTUAL PT DATA WAS PROVIDED, USER INDICATED PT SODIUM'S INITIALLY RESULTING IN THE RANGE OF 128 MMOL/L REPEATED AS 136 TO 138 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE FOUND ISE, SOLUTION BOTTLES EXPIRED IN SOFTWARE, AND REPROGRAMMED ISE SOLUTION BOTTLES. ADDITIONALLY NOTED ISE SOLUTION 2 CALIBRATOR WAS EXPIRED, AND ISE MIXTOWER WAS MISSING AN O-RING. REPLACED ISE SOLUTION 2 AND MISSING O-RING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK