BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1941707 · Received December 30, 2010

    Report

    Report Number
    1628664-2010-00515
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SYSTEM CONTROL CENTER (SCC) POWER SUPPLY ((B)(4)). HE INSPECTED THE BOARDS IN THE CARD CAGE AND POWER SUPPLY. WHEN HE TURNED ON THE ANALYZER, SMOKE WAS EMITTED FROM THE INSTRUMENT AGAIN. THE SMOKE WAS ORIGINATING FROM THE SAMPLE HANDLER LIQUID LEVEL SENSE (LLS) ANTENNA BOARD ((B)(4)) LOCATED UNDER THE SAMPLE PROBE PIPETTOR. THE SAMPLE HANDLER LLS ANTENNA BOARD ALONG WITH THE W68 AND W123 CABLES ((B)(4)) WERE BURNT. THE SAMPLE HANDLER LLS ANTENNA BOARD AND CABLES WERE REPLACED ON THE ANALYZER. A MULTI-POINT INSPECTION WAS PERFORMED ON THE INSTRUMENT AFTER THE COMPONENT REPLACEMENTS. REVIEW OF THE SAFETY MEMO AND PRODUCT EVALUATION INDICATES THE ARCHITECT I2000SR IS CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE. REVIEW OF COMPLAINT DOCUMENTATION DID NOT IDENTIFY AN ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS FOUND FOR THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INSTRUCTIONS INVOLVING ELECTRICAL AND CHEMICAL HAZARDS AND PROVIDES AN EMERGENCY SHUTDOWN PROCEDURE. AFTER THE COMPONENT REPLACEMENT OF THE SCC POWER SUPPLY, SAMPLE HANDLER LLS BOARD, AND CABLES BY FIELD SERVICE, NO ADDITIONAL OCCURRENCES OF THIS ISSUE HAVE BEEN OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THERE WAS A BURNING SMELL AND VISIBLE SMOKE WAS OBSERVED COMING FROM THE ARCHITECT I2000 ANALYZER. THE ANALYZER'S FAN HAD STOPPED AND TEMPERATURE ERRORS WERE GENERATED. THE ANALYZER WAS SHUTDOWN. NO INJURIES OR IMPACT TO THE SURROUNDING ENVIRONMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) SAMPLE HANDLER LLS ANTENNA BOARD| (B)(4) SAMPLE HANDLER LLS ANTENNA BOARD