BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2853537 · Received December 3, 2012

    Report

    Report Number
    1628664-2012-00494
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 10, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THAT IN ADDITION TO THE BURNING SMELL FROM THE ANALYZER, IT WAS ALSO REPORTED THAT ERROR 7109 (TEMPERATURE CONTROLLER BOARD NOT COMMUNICATING) OCCURRED. THE CUSTOMER TURNED THE POWER OFF TO THE ANALYZER. FIELD SERVICE WENT ON-SITE AND CONFIRMED SMOKE FROM THE ANTENNA OF THE SAMPLE HANDLER WHEN POWER WAS STARTED UP. SERVICE REPLACED THE DAMAGED ANTENNA, POWERED ON ANALYZER, AND CONFIRMED NORMAL FUNCTION. THE DAMAGED SAMPLE HANDLER LLS ANTENNA IS NOT AVAILABLE FOR RETURN. A SEARCH OF THE SERVICE HISTORY FOR THE INSTRUMENT FOUND NO OTHER TICKETS RELATED TO THE COMPLAINT UNDER INVESTIGATION. A REVIEW OF METRICS DATA DID NOT IDENTIFY ANY ADVERSE OR NONSTATISTICAL TRENDS FOR THE SAMPLE HANDLER LLS ANTENNA. THE ARCHITECT SYSTEM OPERATIONS MANUAL HAS ADEQUATE LABELING FOR ELECTRICAL HAZARDS OF THE SYSTEM. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION THE INFORMATION REASONABLY SUGGESTS A MALFUNCTION. NO SYSTEMIC PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED SMOKE COMING FROM THE ANTENNA OF THE SAMPLE HANDLER ON THE ARCHITECT I2000SR. THE ACCOUNT TURNED OFF POWER TO THE ANALYZER. NO EXPOSURE OR INJURY WAS REPORTED TO THE OPERATOR. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1