BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1900957 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06779
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 27, 2010
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE LEFT HAND FAN WAS FUNCTIONING SLOWLY AND THERE WAS HEAT DAMAGE TO THE PLANAR WINDING PCB. THERE WAS NO EVIDENCE OF FIRE AND ALL PARTS AND PLASTICS ARE UL RATED ACCORDINGLY. FOR EXISTING POWER SUPPLIES, A CLEANING PROCEDURE HAS BEEN ADDED TO THE HALF YEAR ANALYZER MAINTENANCE REQUIREMENTS AND THE PART IS SCHEDULED TO BE REPLACED EVERY THREE YEARS. FOR NEW POWER SUPPLIES, A RETROFIT KIT HAS BEEN INTRODUCED FOR POWER SUPPLIES THAT DO NOT CURRENTLY INCLUDE THE OVER TEMPERATURE PROTECTION SWITCH. NO INJURY WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE USER STATED "LOTS OF SMOKE" WAS COMING OUT OF THE BACK OF THE ANALYZER. NO ONE INHALED THE SMOKE AND THE LABORATORY DID NOT HAVE TO BE EVACUATED. NO INSTRUMENT OPERATORS OR LAB PERSONNEL WERE HARMED. NO PATIENTS WERE INVOLVED IN THE EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE POWER SUPPLY AND REPLACED IT. HE VERIFIED PROPER OPERATION USING DIAGNOSTIC TESTING. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1