BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAS WORKCELL

    MDR report key: 1210151 · Received October 20, 2008

    Report

    Report Number
    2432235-2008-00122
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    August 29, 2008
    Report Date
    October 1, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS FSE WAS SENT TO THE CUSTOMER SITE AND REPLACED THE BARCODE READER. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REMOVED AN UNLOAD TRAY FROM THE SAMPLE MANAGER'S DRAWER OF THE WORKCELL AFTER RECEIVING A BARCODE MISREAD ERROR. SAMPLE TUBES WERE SPILLED WHEN THE INSTRUMENT FAILED TO UPDATE THE UNLOAD TRAY POSITION, AFTER THE CUSTOMER CLOSED THE SAMPLE DRAWER. THERE IS NO REPORT OF INJURY TO THE SYSTEM OPERATOR. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE LOSS OF PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAS WORKCELL LAB AUTOMATION SYSTEMS JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1