BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE

    MDR report key: 3071053 · Received April 22, 2013

    Report

    Report Number
    2432235-2013-00148
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DISCOVERED THAT THE AUTOSAMPLER NEEDLE HAD BROKEN IN A TUBE. THE FSE REPLACED THE AUTOSAMPLER NEEDLE. THE CAUSE OF THE OPERATOR RECEIVING A NEEDLESTICK WAS A MALFUNCTION OF THE AUTOSAMPLER NEEDLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA 2120 WITH DUAL ASPIRATE INSTRUMENT WAS PUNCTURED BY THE AUTOSAMPLER NEEDLE WHILE HANDLING AN EJECTED SAMPLE RACK. THE NEEDLE PIERCED THE SKIN OF THE OPERATOR'S HAND. THE OPERATOR WAS SENT TO A NEARBY HOSPITAL EMERGENCY ROOM TO HAVE THE WOUND CLEANED AND BASELINE TESTING PERFORMED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NEEDLESTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171359 ADVIA 2120 WITH DUAL ASPIRATE DIFFERENTIAL CELL COUNTER GKZ SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2120 WITH DUAL ASPIRATE

    Patients

    Seq Age Sex Outcome Treatment
    1