BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1080664 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05676
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS A LEAK INSIDE THE ANALYZER THAT WAS DRIPPING WATER DOWN ONTO BOARDS INSIDE THE ANALYZER. NO INJURIES WERE REPORTED. FIELD SVC REP DETERMINED ROOT CAUSE TO BE CRACKED RINSE TUBING OF SV19 AND REPLACED THE TUBING. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK