BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1242911 · Received November 26, 2008

    Report

    Report Number
    1628664-2008-00269
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER SITE AND FOUND A DAMAGED POWER SUPPLY TO THE SYSTEM CONTROL CENTER (SCC) CENTRAL PROCESSING UNIT (CPU) OF THE ARCHITECT I2000SR ANALYZER. THE FSR REPLACED THE SCC CPU AND VERIFIED THAT THE INSTRUMENT WAS OPERATIONAL. UPON ADDITIONAL COMMUNICATION WITH THE COUNTRY, IT WAS DETERMINED THAT THE POWER SUPPLY TO THE SCC CPU WAS ALSO REPLACED. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. A REVIEW OF THE SERVICE HISTORY FOR ARCHITECT ISYSTEM WAS PERFORMED FOR THE TIME PERIOD OF 2008 THRU 2009. NO ADDITIONAL COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED SINCE THE FSR REPLACED THE SCC CPU AND THE POWER SUPPLY TO THE SCC CPU. THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL (MAY, 2008) PROVIDES ADEQUATE INFORMATION ADDRESSING THIS CUSTOMER'S ISSUE. A MALFUNCTION OF THE SYSTEM WAS IDENTIFIED. BASED ON A REVIEW OF THE INSTRUMENT'S SERVICE HISTORY RECORD, SINCE THE FSR REPLACED THE SCC CPU AND THE POWER SUPPLY TO THE SCC CPU, NO REPEATS OF THIS ISSUE HAVE BEEN DETECTED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A BURNING ODOR ACCOMPANIED WITH SMOKE COMING FROM THE ARCHITECT I2000SR ANALYZER. THE SMOKE APPEARS TO BE CONTAINED TO THE SYSTEM CONTROL CENTER (SCC). THERE ARE NO REPORTED INJURIES OR DAMAGE TO THE SURROUNDING ENVIRONMENT. A SERVICE CALL WAS INITIATED. THERE IS NO REPORT OF ANY IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH SCC CPU