BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2023755 · Received March 18, 2011

    Report

    Report Number
    1823260-2011-01492
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE ISSUE WAS CAUSED BY AN OPERATOR HANDLING ISSUE. THE OPERATOR FORGOT TO REOPEN THE WATER TANK JOINT, SO THE SYSTEM RAN DRY WITHOUT WATER. THE COOLING FUNCTION FOR THE LAMP WAS THEN NOT POSSIBLE. PRODUCT LABELING INCLUDES A SPECIAL PRECAUTION TO NOT FORGET THE WATER TANK JOINT AFTER THE MAINTENANCE.

    Description of Event or Problem · 1

    THE USER RECEIVED ANALYZER ALARMS AND FOUND THE LINES GOING INTO THE WATER TANK WERE NOT OPEN. WHEN THE USER ATTEMPTED TO CHANGE THE REACTION CELLS AND THE LAMP, SHE BURNT HER FINGER ON THE INCUBATOR BATH SCREW. THE USER STATED THE BURN WAS NOT SERIOUS AND WAS JUST "A TINY, LITTLE BLISTER ON HER FINGER". THE USER DID NOT SEEK MEDICAL ATTENTION FOR THE INJURY AND STATED HER CURRENT CONDITION WAS "FINE". WHEN THE USER REMOVED THE LAMP, SHE NOTED THE WIRE ON THE LAMP WAS MELTED. NO PATIENTS WERE INVOLVED IN THE ISSUE AND NO ERRONEOUS RESULTS WERE GENERATED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE USER DID NOT OPEN WATER SUPPLY ASSEMBLY TANK VALVES THAT WERE FEEDING THE ANALYZER. THE PHOTOMETER HAD AN ELEVATED TEMPERATURE WHICH MELTED THE LAMP WIRE DUE TO NO WATER FLOW THROUGH. HE CORRECTED THE VALVES, PRIMED THE SYSTEM, PURGED AIR FROM THE SYSTEM, PERFORMED WATER EXCHANGES, VERIFIED WATER FLOWING THROUGH THE PHOTOMETER, REPLACED THE LAMP, REPLACED THE HEAT CUT FILTER AND CLEANED THE BATH WINDOW. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS WHICH PASSED SPECIFICATIONS AND THE USER RAN CALIBRATION AND QUALITY CONTROL WHICH PASSED PER THE CUSTOMER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1