BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1880094 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06321
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED A POWER OUTAGE IN THE LABORATORY JUST PRIOR TO AN INSTRUMENT ALARM APPEARING ON THE COBAS INTEGRA 800. THE CUSTOMER REPLACED THE F3 FUSE AND REBOOTED THE ANALYZER. SHE SMELLED A BURNING ODOR AND NOTICED THE FUSE HOLDER APPEARED TO BE MELTED. NO PATIENTS WERE INVOLVED IN THIS EVENT AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE F3 FUSE CAP WAS THE CAUSE. HE REPLACED THE F3 FUSE ASSEMBLY AND OBSERVED PROPER ANALYZER OPERATION.

    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