BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1712146 · Received June 7, 2010

    Report

    Report Number
    1628664-2010-00232
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED BURNED LAMP WIRES WHEN CHANGING A LAMP ON THE ARCHITECT C8000 ANALYZER. THE ACCOUNT WAS GENERATING ERROR CODE 1054 ON MULTIPLE SAMPLES. THROUGH TROUBLESHOOTING, THE ACCOUNT CHANGED THE LAMP BUT NOTICED THE LAMP WIRES WERE BURNED. AFTER CHANGING THE LAMP, THE OPERATOR'S HANDS WERE BLACK WITH BURNED MATERIAL. AFTER CHANGING THE LAMP NO MORE ARCHITECT ERROR CODES WERE GENERATED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1