BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120

    MDR report key: 2222230 · Received August 24, 2011

    Report

    Report Number
    2432235-2011-00111
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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 OF THE DISCORDANT RESULT WAS INADEQUATE MANUAL SAMPLE MIXING OF THE SAMPLE TUBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR HEMOGLOBIN (HGB) WERE OBTAINED ON AN ADVIA 2120 INSTRUMENT. THE SAMPLES WERE RE-TESTED AND THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT HEMOGLOBIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1