BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3130737 · Received May 24, 2013

    Report

    Report Number
    2432235-2013-00192
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO TURN OFF THE INSTRUMENT, WHICH THE CUSTOMER DID. THE TSC SPECIALIST ORDERED PARTS RELATED TO THE DILUTION PROBE AREA FOR A FIELD SERVICE VISIT. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA 2400 INSTRUMENT RECEIVED AN ERROR MESSAGE THAT A TEST WAS NOT COMPLETED. THE OPERATOR THEN OBSERVED SMOKE COMING FROM THE DILUTION PROBE AREA OF THE INSTRUMENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE FROM THE DILUTION PROBE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230939 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1