BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 5191928 · Received October 30, 2015

    Report

    Report Number
    2432235-2015-00508
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 4, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS, INC. (SIEMENS). SIEMENS DETERMINED THAT THE CAUSE OF THE EVENT IS DUE TO THE CUSTOMER NOT FOLLOWING OPERATOR GUIDE INSTRUCTIONS WHEN PERFORMING MAINTENANCE ON THE CENTERING COLLAR. THE OPERATOR GUIDE STATES "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 CENTERING COLLAR. BE CAREFUL NOT TO BEND THE NEEDLE AS YOU SLIP THE COVER OVER IT.". THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER WAS PERFORMING MAINTENANCE AROUND THE CENTERING COLLAR ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE CUSTOMER REMOVED THE CENTERING COLLAR TO CLEAN AROUND THE NEEDLE SITE AND DID NOT PUT THE RED NEEDLE COVER IN PLACE. THE CUSTOMER'S HAND SLIPPED AND THE AUTOSAMPLER NEEDLE PIERCED THEIR INDEX FINGER, WHICH WAS IMMEDIATELY BLED AND WAS WASHED UNDER RUNNING TAP WATER. ON (B)(6) 2015, THE CUSTOMER WENT TO THEIR OCCUPATIONAL HEALTH GROUP FOR A HEPATITIS B BOOSTER AND BLOOD SAMPLES WERE TAKEN IN THE EVENT OF LATER DEVELOPMENTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722562 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