BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1893775 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06645
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE RESULT FOR CREATININE ON THE INTEGRA 800 ANALYZER FOR ONE PATIENT SAMPLE. THE PATIENT WAS AN OUTPATIENT. THE PATIENT SAMPLE WAS REPEATED ON A COBAS 6000 ANALYZER. THE INITIAL CREATININE RESULT WAS 2.5 MG/DL, THE REPEAT RESULT WAS 0.8 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE REAGENT LOT NUMBER FOR CREATININE JAFFE WAS 63093101. THE FIELD SERVICE REPRESENTATIVE DETERMINED FLUIDICS FAILURE WAS THE CAUSE. HE REPLACED MULTIPLE COMPONENTS. PERFORMANCE TESTS WERE RUN WHICH PASSED WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR