BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1051584 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04135
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT GLUCOSE RESULTS. INITIAL RESULT GAVE 56 MG/DL. NEXT DAY, SAMPLE WAS REPEATED THREE TIMES GIVING 160, 89 AND 169 MG/DL. SAMPLE WAS SENT TO ANOTHER FACILITY WHICH GAVE A GLUCOSE RESULT OF 182 MG/DL. INITIAL RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE OF THE DISCREPANCY TO BE DUE TO A MISADJUSTED PROBE AND REAGENT PROBE ALIGNMENT POST. ADJUSTED ALIGNMENT POST AND REPLACED PROBE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    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 62 YR