BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5363100 · Received January 13, 2016

    Report

    Report Number
    2432235-2016-00010
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    December 30, 2015
    Report Date
    December 30, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE ADVIA (B)(4) ONLINE OPERATOR GUIDE V6.01 INSTRUCTIONS WHEN PERFORMING MAINTENANCE ON THE CENTERING COLLAR BY USING WARM DISTILLED WATER TO LOOSEN THE CENTERING COLLAR PRIOR TO REMOVING IT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2016-00010) ON JANUARY 13, 2016. JANUARY 19, 2016 - CORRECTED INFORMATION: THE INSTRUMENT INVOLVED IN THE EVENT WAS THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER AND NOT THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER. THIS INFORMATION WAS CORRECTED.

    Description of Event or Problem · 1

    DURING THE DAILY MAINTENANCE PROCEDURE, THE CUSTOMER INJURED HER FINGER WITH THE AUTOSAMPLER NEEDLE WHEN TRYING TO REMOVE THE CENTERING COLLAR ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE CUSTOMER DID INITIATE THE PROCEDURE IN ACCORDANCE WITH THE RULES OF PROCEDURE OF THE HOSPITAL; HOWEVER, IT IS UNKNOWN IF THE CUSTOMER RECEIVED FIRST AID OR PROPHYLACTIC TREATMENT. THERE ARE NO KNOWN ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER'S FINGER BEING STUCK BY THE AUTOSAMPLER NEEDLE ON THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT.

    Description of Event or Problem · 1

    THE INSTRUMENT INVOLVED IN THE EVENT WAS THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER, NOT THE ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21985 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1