BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 5743297 · Received June 22, 2016

    Report

    Report Number
    2432235-2016-00334
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 8, 2016
    Report Date
    June 22, 2016
    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 STATED SHE FOLLOWED THE PROCEDURE IN THE ADVIA 2120I OPERATOR GUIDE WHEN PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. SHE WAS INJURED WHILE REMOVING THE CENTERING COLLAR AND BEFORE THE RED NEEDLE GUARD WAS PUT IN PLACE OVER THE AUTOSAMPLER NEEDLE. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE CAUSE OF THE NEEDLESTICK INJURY TO THE FINGER WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT IS OPERATOR'S TECHNIQUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER SUSTAINED A NEEDLE STICK INJURY TO THEIR FINGER WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT. THE INCIDENT OCCURRED AS THE CUSTOMER WAS REMOVING THE CENTERING COLLAR DURING THE MAINTENANCE PROCEDURE. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. AS PER THE HOSPITAL'S LAB PROCEDURE, THE CUSTOMER VISITED THE ACCIDENT AND EMERGENCY DEPARTMENT IN THE HOSPITAL AND THE WOUND WAS ENCOURAGED TO BLEED. THERE WAS NO PROPHYLACTIC TREATMENT RECEIVED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER BEING INJURED WHILE PERFORMING THE CENTERING COLLAR MAINTENANCE ON THE ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396103 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