BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER

    MDR report key: 11339896 · Received February 17, 2021

    Report

    Report Number
    2432235-2021-00046
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 19, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2021-00046 ON 17-FEB-2021. ADDITIONAL INFORMATION (02-MAR-2021): THE CUSTOMER WAS NOT WEARING THE RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. AS PER THE ADVIA 120/2120/2120I HEMATOLOGY SYSTEM OPERATOR'S GUIDE: "ALL PRODUCTS OR OBJECTS THAT COME IN CONTACT WITH HUMAN OR ANIMAL BODY FLUIDS SHOULD BE HANDLED, BEFORE AND AFTER CLEANING, AS IF CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. WEAR FACIAL PROTECTION, GLOVES, AND PROTECTIVE CLOTHING." THE CAUSE OF THE EVENT IS USE ERROR. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    WHILE REPLACING REAGENTS ON THE LABORATORY'S ADVIA 120 HEMATOLOGY SYSTEM, DROPS OF ADVIA 120/2120/2120I DIFF TIMEPAC REAGENT SPLASHED INTO THE CUSTOMER'S EYE, CAUSING IRRITATION. THE CUSTOMER WAS NOT WEARING EYE PROTECTION AT THE TIME OF THE EVENT. THE CUSTOMER WASHED HER EYE WITH WATER FOR 10 MINUTES, AND WAS PRESCRIBED EYE DROPS BY HER OPHTHALMOLOGIST. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234174 ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120 HEMATOLOGY SYSTEM WITH AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1