BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120

    MDR report key: 2540335 · Received April 19, 2012

    Report

    Report Number
    2432235-2012-00127
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 9, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER ( FSE) EVALUATED THE ADVIA 120 INSTRUMENT AND INSTRUMENT DATA. THE FSE FLUSHED ALL THE PATHWAYS. REPLACED THE RBC SAMPLE SYRINGE AND THE FLOWCELL TUBING, REFOCUSED THE LASER WITH OPTIPOINT AND ADJUSTED THE GAINS ACCORDINGLY, RAN QC. THE SYSTEM IS OPERATIONAL. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA 120 HEMAGLOBIN ( HGB) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE LABORATORY REPEATED THE SAMPLE AND A NEW SAMPLE WAS REDRAWN AND TESTED. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THE NURSING HOME PATIENT WAS SENT TO THE HOSPITAL. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HGB RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1