BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1060126 · Received June 11, 2008

    Report

    Report Number
    1823260-2008-04655
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT GLUCOSE RESULTS. INITIAL RESULT GAVE 241 MG/DL; REPEATED TWICE GIVING 106 AND 105 MG/DL. INITIAL RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE FOR THE DISCREPANCY TO BE DUE TO A BENT RT1 SR PROBE AND REPLACED RT1 PROBES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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