BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 911032 · Received September 13, 2007

    Report

    Report Number
    1628664-2007-00420
    Event Type
    Other
    Date Received
    September 13, 2007
    Date of Event
    August 28, 2007
    Report Date
    August 30, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND OBSERVED THE LIQUID LEVEL SENSE (LLS) BOARD WAS BURNT. THE LLS CARD R V1-2 ANTENNA BOARD CAUGHT FIRE DUE TO BUFFER FAILING ON THE BOARD FROM THE VALVE OF THE F1 SYRINGE. THE R1 ASSEMBLY WAS WET. THE FSR REPLACED THE SYRINGE ASSEMBLY AND THE R1-R2 LLS ANTENNA. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT LEAKAGE FROM THE R1 SYRINGE ON THE ARCHITECT I2000 ANALYZER CAUSED THE LIQUID LEVEL SENSE CIRCUIT BOARD TO SHORT OUT AND GENERATE SMOKE, WHICH WAS INHALED BY THE OPERATOR. AFTERWARDS, THE OPERATOR REPORTED A SORE THROAT. NO MEDICAL TREATMENT WAS RECEIVED AND THE OPERATOR IS DOING FINE. THERE WAS NO DAMAGE TO THE SURROUNDING ENVIRONMENT. A SERVICE CALL WAS INITIATED. THERE IS NO FURTHER IMPACT TO THE OPERATOR REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR