BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1061938 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04748
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT URINE SAMPLES WITH DISCREPANT CREATININE RESULTS. PATIENT 1, INITIAL RESULT GAVE <0.0 MG/DL; REPEAT GAVE 0.3 MG/DL. PATIENT 2, INITIAL RESULT GAVE <0.0 MG/DL; REPEAT GAVE SAME RESULT. SAMPLE REPEATED ON 05/21/2008 GIVING 38.3 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE CUSTOMER REPLACED PROBES WHICH RESOLVED THE ISSUE.

    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