BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120

    MDR report key: 2133034 · Received June 17, 2011

    Report

    Report Number
    2432235-2011-00090
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042251
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR# 2432235-2011-00090 ON (B)(4) 2011. UPDATED (B)(4) 2012: SIEMENS RELEASED URGENT FIELD SAFETY NOTICE #(B)(4) IN (B)(4) 2011, TO ADVISE CUSTOMERS AND SERVICE PERSONNEL OF THE CORRECT PPE TO BE USED WHEN PERFORMING A TROUBLESHOOTING PROCEDURE USING EZ KLEEN.

    Additional Manufacturer Narrative · 1

    THE OPERATOR WAS WEARING A GOWN, GLOVES AND SAFETY GLASSES. DURING THE MAINTENANCE PROCEDURE, A REAGENT TUBING LINE POPPED OFF AND CAUSED THE EZKLEEN REAGENT TO SPLASH ON THE OPERATOR. THE LIQUID SPLASHED ON HIS FOREHEAD AND THEN TRICKLED DOWN INTO HIS EYE BEHIND THE SAFETY GLASSES. THE TUBING LINE WAS RE-CONNECTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    EZ KLEEN REAGENT FLUID WAS PROJECTED ONTO THE OPERATOR'S FACE WHILE PERFORMING MAINTENANCE ON AN ADVIA 2120 INSTRUMENT. THE OPERATOR WAS DIAGNOSED WITH A CORNEAL ABRASION AND RECEIVED ANTIBIOTIC DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 HEMATOLOGY ANALYZER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1