BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1780195 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08259
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 3, 2007
    Report Date
    September 21, 2007
    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

    APPROX 35 PT SAMPLES WITH HIGH RECOVERY FOR CALCIUM. ONLY ONE PT EXAMPLE WAS PROVIDED AS FOLLOWS: INITIAL CALCIUM RESULT OF 8.5 MG/DL. SAME SAMPLE REPEATED RECOVERED 7.1 MG/DL. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS A PROBLEM WITH THE REAGENT AND CALIBRATORS.

    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 NA