BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I

    MDR report key: 2042734 · Received April 6, 2011

    Report

    Report Number
    2432235-2011-00050
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FOUND TUBING LOOSE AND ALLOWING AIR TO DISPLACE RANDOM AMOUNTS OF SAMPLE. HE APPLIED LOCKTITE TO FITTING THREADS AND SECURED THE AUTOSAMPLER TUBE TO THE ASPIRATE NEEDLE ASSEMBLY. THE FSE CALIBRATED THE SYSTEM AND RAN QC'S. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR HEMOGLOBIN AND HEMATOCRIT WERE OBTAINED ON AN ADVIA 2120I INSTRUMENT. THE DISCORDANT LOW RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDER(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1