BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 4551949 · Received February 26, 2015

    Report

    Report Number
    2432235-2015-00100
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 9, 2015
    Manufacturer
    SIMENES HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND DETERMINED THAT THE REAGENT PUMP ASSEMBLY WAS DEFECTIVE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE REAGENT PUMP ASSEMBLY WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE DISCREPANT, HIGH WHITE BLOOD CELL PEROXIDASE (WBCP) AND DIFFERENTIAL RESULTS ON THE INSTRUMENT WAS THE DEFECTIVE REAGENT PUMP ASSEMBLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) REPORTED RANDOM, DISCREPANT HIGH RESULTS ON THE WHITE BLOOD CELL PEROXIDASE (WBCP) AND DIFFERENTIAL RESULTS FOR TWO PATIENT SAMPLES ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE CUSTOMER SUSPECTED ANY FLAGGED RESULTS AND RERAN ANY SAMPLES WITH ISSUES. THE RERUN RESULTS FOR BOTH PATIENT SAMPLES WERE REPORTED TO THE PHYSICIANS. NO QUALITY CONTROL DATA WAS PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED WBCP AND DIFFERENTIAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137207 ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER ADVIA 2120I WITH SINGE ASPIRATE AUTOSAMPLER GKZ SIMENES HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1