BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN ANALYZER

    MDR report key: 482927 · Received August 27, 2003

    Report

    Report Number
    2243471-2003-00002
    Event Type
    Malfunction
    Date Received
    August 27, 2003
    Date of Event
    July 29, 2003
    Report Date
    August 27, 2003
    Manufacturer
    ROCHE INSTRUMENT CENTER
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROCHE MOLECULAR SYSTEM, INC. (RMS) IN PLEASANTON, CALIFORNIA RECEIVED A REPORT FROM THE USER FACILITY THAT IN 2003 THE PLEXIGLAS COVER ON THE COBAS TAQMAN ANALYZER SLID CLOSED FROM THE OPEN POSITION STRIKING THE ANALYST WHO WAS USING THE ANALYZER. THE ANALYST TEMPORARILY LOSS CONSCIOUSNESS, WAS TAKEN TO THE HOSPITAL AND WAS RELEASED THE FOLLOWING AFTERNOON. THE ASST LAB MANAGER OF THE USER FACILITY NOTIFIED THE ROCHE DIAGNOSTICS AFFILIATE OF THE EVENT ON THE SAME DAY, IN 2003. THE COBAS TAQMAN ANALYZER IS MANUFACTURED FOR RMS AT THE ROCHE INSTRUMENT CENTER (RIC) LOCATED IN ROTKREUZ, SWITZERLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQMAN ANALYZER MICRO CHEMISTRY ANALYZER FOR CLINICAL US JJF ROCHE INSTRUMENT CENTER SERIES 96 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O