BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1962622 · Received January 18, 2011

    Report

    Report Number
    1628664-2011-00049
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 27, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR NOTED THAT THE R1 SYRINGE HAD A LEAK WHICH CAUSED THE RV 1-2 ANTENNA TO SHORT CIRCUIT. THE FSR REPLACED THE SYRINGE AND THE LLS ANTENNA, RV 1-2 AND STAT. THE FSR INDICATED THE INSTRUMENT WAS PERFORMING ACCORDING TO SPECIFICATIONS. A REVIEW OF THE RISK REDUCTION MEMO INDICATES THE ARCHITECT I2000SR IS CERTIFIED TO THE APPROPRIATE (B)(4) SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO PROVIDE ADEQUATE INFORMATION REGARDING ELECTRICAL HAZARDS AND AN EMERGENCY SHUTDOWN PROCEDURE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSE) NOTED A SMELL OF MELTED ALUMINUM AND OBSERVED SMOKE COMING FROM THE SYRINGE AREA ON THE ARCHITECT I2000 ANALYZER. THERE WAS NO INJURY 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