BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1929416 · Received December 15, 2010

    Report

    Report Number
    1823260-2010-07466
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 5, 2010
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. IT WAS DETERMINED POSSIBLE CAUSES ARE A COMBINATION OF EXCESSIVE AMOUNT OF CEMENT USED TO FIX THE LAMP INTO THE SOCKET, BROKEN CEMENT WITH FORMATION OF VOIDS, AND THE LAMP TEMPERATURE. THIS CAN CAUSE A CERTAIN TENSION INSIDE THE GLASS AND BRING IT OVER ITS TENSION LIMIT. THE PROBLEMS OF EXCESSIVE CEMENT AND FORMATION OF VOIDS HAVE BEEN ADDRESSED PROCEDURES INCLUDING CAUTIONS FOR LAMP REPLACEMENT ARE DESCRIBED IN THE OPERATOR'S MANUAL. NO PATIENT OR OPERATOR WAS INVOLVED OR HARMED IN THIS ISSUE.

    Description of Event or Problem · 1

    THE USER EXPERIENCED ANALYZER ALARMS AND ATTEMPTED TO REPLACE THE PHOTOMETER LAMP. WHEN THE CUSTOMER UNSCREWED THE LAMP, IT "EXPLODED SENDING GLASS ALL OVER THE PHOTOMETER HOUSING". SHE STATES THE "LAMP SHATTERED UNDER FORCE ENOUGH TO SENDING SHARDS OF GLASS FLYING INTO AND AROUND THE LAMP HOUSING WERE SHE WAS UNSCREWING THE LAMP." THE CUSTOMER USED A VACUUM TO SUCK UP THE BROKEN GLASS AND THEN REMOVED THE LAMP BASE AND WIRING FROM THE PHOTOMETER. THE USER STATED NO ONE WAS HARMED IN ANY WAY. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE CHECKED THE LAMP HOUSING AND VOLTAGE AT THE CONNECTOR. THE USER INSTALLED A NEW LAMP WHICH PASSED INITIALIZATION AND AN AIR/WATER CALIBRATION. THE USER RAN QUALITY CONTROL WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1