BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1691507 · Received May 17, 2010

    Report

    Report Number
    1628664-2010-00204
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CURRENT COMPLAINT IS THE SOLE COMPLAINT IDENTIFIED IN THE REVIEW. THE ARCHITECT SYSTEM OPERATIONS MANUAL P/N 201837-106, JANUARY 2009 AND THE ARCHITECT ISYSTEM SERVICE AND SUPPORT MANUAL ((B) (4) PROVIDE INFORMATION TO ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A MALFUNCTION OF THE ARCHITECT SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT SHE BROKE HER RIGHT TOE WHILE PERFORMING MAINTENANCE ON THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER HAD OPENED THE REAR ACCESS PANEL TO CHECK THE INSIDE OF THE ANALYZER AND HAD LEANED THE OUTER EDGE OF THE PANEL AGAINST HER BODY. WHEN SHE MOVED, THE COVER FELL WITH THE METAL BRACKET OF THE COVER LANDING ON HER FOOT. X-RAYS OF THE FOOT FOUND NO OTHER DAMAGE. THE CUSTOMER WAS OFF FROM WORK FOR TWO DAYS WITH SWELLING OF THE FOOT BUT SINCE HAS RETURNED. THE CUSTOMER HAS TRIED SEVERAL TIMES TO RECREATE THE COVER FALLING BUT HAS BEEN UNSUCCESSFUL. SINCE THEN, THE LAB HAS INITIATED A POLICY THAT WHENEVER THE REAR ACCESS PANEL IS TO BE OPENED, IT IS TO BE COMPLETELY REMOVED FROM THE ANALYZER.

    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 Disability PANEL ACCESS REAR PROCESS PANEL PN:7-76710-01