BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTCYCLER 2.0

    MDR report key: 2151776 · Received July 6, 2011

    Report

    Report Number
    1823260-2011-03631
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT UPON ENTERING THE LABORATORY SHE SMELLED A STRONG ODOR RESEMBLING AN ELECTRICAL FIRE. NO SMOKE WAS OBSERVED. THE CUSTOMER IDENTIFIED THE SOURCE AS COMING FROM THEIR LIGHTCYCLER 2.0 (SERIAL NUMBER (B)(4)). SECURITY INVESTIGATED THE LABORATORY AND DETERMINED THERE WAS NO ELECTRICAL FIRE. THE CUSTOMER DID NOT BELIEVE THERE HAD BEEN A POWER SURGE AS NONE OF THE OTHER EQUIPMENT PLUGGED INTO THE SAME WALL HAD BEEN AFFECTED. THE CUSTOMER STATED NO ONE WAS INJURED. INVESTIGATION OF THE EVENT DETERMINED THE FAN TO THE POWER SUPPLY STOPPED WORKING AND THIS CAUSED THE POWER SUPPLY TO OVERHEAT, AS A RESULT, THE ELECTRONIC ELEMENTS BURNT AND THE CONTROL UNIT STOPPED WORKING. NO ADDITIONAL COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED RELATED TO THE CONTROL UNIT. THE ISSUE IS DETECTABLE AS CONTROL UNIT WILL STOP WORKING IMMEDIATELY. THE COMPONENTS ARE UL CERTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTCYCLER 2.0 CHEMISTRY/MICRO ANALYZER JJF ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1