BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA

    MDR report key: 510207 · Received January 12, 2004

    Report

    Report Number
    1823260-2004-00008
    Event Type
    Malfunction
    Date Received
    January 12, 2004
    Date of Event
    August 18, 2003
    Report Date
    August 19, 2003
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ORIGINAL GLUCOSE RESULT FOR A PT SAMPLE WAS 90 MG/DL. WHEN RETESTED, THE RESULT WAS 331 MG/DL. FIELD SERVICE REP REPLACED THE SAMPLE NEEDLE AND SYRINGE TIP TO REPAIR THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS MIRA CLINICAL CHEMISTRY ANALYZER JJF ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other