BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120

    MDR report key: 2441554 · Received February 7, 2012

    Report

    Report Number
    2432235-2012-00024
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVIA 2120 SOFTWARE VERSION 5.8 HAD BEEN INSTALLED IN THE CUSTOMER'S ADVIA 120 ANALYZER BY A SIEMENS FIELD SERVICE ENGINEER (FSE). SIEMENS BECAME AWARE OF THE INSTALLATION OF THE ADVIA 2120 SOFTWARE IN THE ADVIA 120 ANALYZER WHEN A SIEMENS FSE WAS DISPATCHED TO INSTALL A SECOND ADVIA 120 ANALYZER AT THE CUSTOMER'S FACILITY. THE CUSTOMER STOPPED USING THE ADVIA 120 ANALYZER WITH INCORRECT SOFTWARE AS OF (B)(6) 2012. A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATING THE INSTRUMENT, THE FSE REMOVED THE ADVIA 2120 VERSION 5.8 SOFTWARE AND INSTALLED THE CORRECT ADVIA 120 SOFTWARE VERSION 3.2.3. THE CUSTOMER THEN RESUMED USING THE ADVIA 120. THE ANALYZER IS OPERATING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE ANALYZER IS REQUIRED.

    Description of Event or Problem · 1

    ADVIA 2120 SOFTWARE VERSION 5.8 WAS INSTALLED ON AN ADVIA 120 HEMATOLOGY ANALYZER. THE CUSTOMER NOTED THAT THE ADVIA 120 ANALYZER WAS USED TO GENERATE RETI (RETICULOCYTE) PARAMETERS ONLY, WHICH WERE REPORTED OUT FOR APPROXIMATELY FORTY (40) PATIENTS OVER A PERIOD OF FOUR (4) MONTHS. THERE WERE NO KNOWN REPORTS OF DISCORDANT PATIENT VALUES OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INSTALLATION OF THE ADVIA 2120 SOFTWARE ON THE ADVIA 120 ANALYZER. THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING DELAYED, ALTERED, OR PRESCRIBED DUE TO THE INSTALLATION OF THE ADVIA 2120 SOFTWARE ON THE ADVIA 120 ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 120 HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120

    Patients

    Seq Age Sex Outcome Treatment
    1