BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1315969 · Received December 1, 2008

    Report

    Report Number
    1823260-2008-08831
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 15, 2008
    Report Date
    December 2, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A LEAK COMING FROM THE ANALYZER. THE LEAK CAME FROM THE BACK OF THE INSTRUMENT AND REACHED THE FLOOR. NO PATIENT SAMPLES WERE INVOLVED AND NO ONE WAS INJURED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A LEAKING RESERVOIR PUMP. HE REPLACED THE RESERVOIR PUMP AND PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK