BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5461692 · Received February 25, 2016

    Report

    Report Number
    2432235-2016-00094
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    December 23, 2015
    Report Date
    February 4, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED SHE FOLLOWED THE ADVIA 2120 OPERATOR GUIDE INSTRUCTIONS AND COVERED THE AUTOSAMPLER NEEDLE WITH THE RED NEEDLE COVER IMMEDIATELY AFTER REMOVING THE CENTERING COLLAR ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE CUSTOMER DID NOT RECEIVE ANY TREATMENT BEYOND FIRST AID FOR THE NEEDLESTICK INJURY TO THEIR FINGER. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE CAUSE OF THE NEEDLESTICK INJURY TO THE CUSTOMER'S FINGER ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT IS OPERATOR'S TECHNIQUE WHEN PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER SUSTAINED A NEEDLESTICK INJURY TO THE FINGER WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE CUSTOMER WENT TO EMPLOYEE HEALTH AND THEN TO THEIR EMERGENCY ROOM TO BE SEEN AND DECLINED ANY MEDICATION. THE FINGER WAS WASHED AND A BANDAID WAS APPLIED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER SUSTAINING A NEEDLESTICK INJURY WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118401 ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR