BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 5412928 · Received February 5, 2016

    Report

    Report Number
    2432235-2016-00054
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 15, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2016-00054) ON FEBRUARY 5, 2016. FEBRUARY 8, 2016 - CORRECTED DATA: THE INITIAL MDR STATED THAT THE CAUSE OF THE EVENT WAS USER INTERVENTION. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS DETERMINED THAT THE CAUSE OF THE EVENT IS USER ERROR.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC.'S (SIEMENS) INVESTIGATION DETERMINED THAT THE CUSTOMER WAS CHANGING A PART ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT THAT IS NOT A CUSTOMER CHANGEABLE PART. THE CABLE ASSEMBLY - RINSE/WASTE LEVEL SWITCH IS NOT LISTED ON THE CUSTOMER REPLACEABLE ITEMS: LIST OF REPLACEABLE PARTS ON THE ADVIA 120/2120/2120I ON LINE HELP OPERATOR'S GUIDE V6.01. SIEMENS HAS DETERMINED THAT THE CAUSE OF THE EVENT IS USER INTERVENTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER INJURED HIS HAND WHEN REPLACING THE CABLE ASSEMBLY-RINSE/WASTE LEVEL SWITCH ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE INJURY WAS ABOUT 1 CENTIMETER (CM) IN LENGTH ON THE CUSTOMER'S HAND. THE INJURY WAS DISINFECTED WITH ISOPROPYL ALCOHOL AND A STERILE DRESSING WAS APPLIED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER INJURING THEIR HAND WHEN REPLACING THE CABLE ASSEMBLY-RINSE/WASTE LEVEL SWITCH ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71895 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