BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 6630439 · Received June 9, 2017

    Report

    Report Number
    2432235-2017-00357
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 29, 2017
    Report Date
    June 9, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE CAUSE OF THE NEEDLESTICK INJURY TO THE CUSTOMER'S FINGER ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT IS THE OPERATOR'S TECHNIQUE WHEN PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE INSTRUMENT. THE ADVIA 120/ 2120/ 2120I HEMATOLOGY SYSTEM OPERATOR'S GUIDE STATES THE FOLLOWING: "TO AVOID PERSONAL INJURY AND EXPOSURE TO A POTENTIAL BIOHAZARD, YOU MUST COVER THE NEEDLE WITH THE RED NEEDLE COVER IMMEDIATELY AFTER YOU REMOVE THE ENTERING COLLAR." THE OPERATOR FAILED TO FOLLOW THE OPERATOR'S GUIDE INSTRUCTIONS AND DID NOT COVER THE AUTO SAMPLER NEEDLE WITH THE RED NEEDLE STICK COVER IMMEDIATELY AFTER REMOVING THE CENTERING COLLAR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR SUSTAINED A NEEDLESTICK INJURY TO THE FINGER WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE PROCEDURE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE OPERATOR WENT TO HEALTH SERVICE IN THE SAME HOSPITAL WHERE SHE SUSTAINED HER INJURY. THE HOSPITAL FOLLOWED THE PROTOCOL OF A BIOLOGICAL RISK AND PERFORMED A BLOOD TEST FOR HEPATITIS C VIRUS (HCV), HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS B SURFACE (HBS) FOR THE OPERATOR. THE OPERATOR RECEIVED RETROVIRAL TREATMENT. 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 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412463 ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR