BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1133560 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06369
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPERATOR REPORTS THE RINSE BATH ON THE ISE UNIT WAS OVERFLOWING, CAUSING A LEAK ON THE FLOOR BEHIND THE INSTRUMENT. NO ONE WAS HARMED. NO PT SAMPLES WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A CLOT IN THE RINSE WELL TO BE THE CAUSE. HE REMOVED AND FLUSHED THE WASTE TUBING. HE PERFORMED MECHANICAL CHECKS, AND VERIFIED THE RINSE WELL WAS DRAINING CORRECTLY. FOLLOW UP WITH CUSTOMER FOUND NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK