BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4143472 · Received October 6, 2014

    Report

    Report Number
    2432235-2014-00584
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS (SIEMENS) CLINICAL SERVICE ENGINEER (CSE) SUBMITTED THE COMPLAINT REGARDING AN ERRONEOUS BARCODE READ ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE EVENT IS DUE TO THE CUSTOMER USING CODE 39 BARCODE SYMBOLOGY WITHOUT A CHECK DIGIT. AS PER THE ADVIA 2120I OPERATOR GUIDE, SIEMENS RECOMMENDS THE USE OF CODE 39 WITH THE CHECK DIGIT ACTIVE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    PATIENT SAMPLE IDENTIFICATION (SID) NUMBER (B)(4) WAS MISREAD AS (B)(4) ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER. THE LAB DID NOT HAVE ANY WORK ORDERS FOR (B)(4). THE OPERATOR MANUALLY ASSOCIATED THE RESULTS WITH (B)(4) AND REPORTED THE RESULTS TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT SID BEING ASSOCIATED WITH THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623205 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