BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 2900266 · Received January 7, 2013

    Report

    Report Number
    2432235-2013-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    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

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE FOR THE DISCORDANT RESULTS WAS A LEAKING CLOT DETECTOR. THE FSE REMOVED AND REPLACED THE CLOT DETECTOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT MULTIPLE DISCREPANT ION SELECTIVE ELECTRODE (ISE) RESULTS WERE GENERATED BY THE ADVIA 2400 SYSTEM. THE RESULTS WERE NOT FLAGGED BY THE SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED ON ANOTHER SYSTEM AND YIELDED RESULTS WITHIN EXPECTATIONS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6552 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1