BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WTH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 3944407 · Received July 18, 2014

    Report

    Report Number
    2432235-2014-00448
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE CUSTOMER WAS USING CODE 39 WITHOUT CHECK DIGIT AS THE BARCODE TYPE, WHICH CAN CONTRIBUTE TO THE BARCODE MIS-READ. THE FSE MODIFIED THE INSTRUMENT'S BARCODE PARAMETER TO ADD A CHECK DIGIT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS INC. AND REPORTED THAT THERE WAS A BARCODE MIS-READ ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER. A SAMPLE WAS ANALYZED BY THE AUTOSAMPLER IN RACK 30 POSITION 9 AND THE SAMPLE IDENTIFICATION NUMBER READ BY THE BARCODE READER WAS (B)(6). THE CUSTOMER NOTICED THAT THE PREVIOUS RESULTS FOR THIS PATIENT DID NOT MATCH WITH THIS RUN. THE CUSTOMER LOOKED AT RACK 30 POSITION 9 AND IT HELD SAMPLE IDENTIFICATION NUMBER (B)(6). NO RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLE WAS NOT REPEATED TO CONFIRM THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SAMPLE IDENTIFICATION MIS-READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421397 ADVIA 2120I WTH 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