BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4120615 · Received September 26, 2014

    Report

    Report Number
    2432235-2014-00568
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE ISSUE AND HAS DETERMINED THAT THE CAUSE OF THE EVENT WAS DUE TO OPERATOR ERROR. THE OPERATOR INCORRECTLY MODIFIED THE SAMPLE IDENTIFICATION NUMBER ON A NON-BARCODED SAMPLE ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER. THIS RESULTED IN THE RESULTS FOR SAMPLE TUBE 7 TO CROSS TO THE LABORATORY INFORMATION SYSTEM (LIS) AS THOSE FOR SAMPLE TUBE 6. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    INCORRECT RESULTS WERE RELEASED FROM THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER FOR SAMPLE IDENTIFICATION NUMBER (B)(6). THE LAB CAUGHT THE DISCREPANCY AND NOTIFIED THE PHYSICIAN BEFORE THEY SAW THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT RESULTS BEING RELEASED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600516 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1