BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX K-1000

    MDR report key: 450883 · Received March 31, 2003

    Report

    Report Number
    1422681-2003-00001
    Event Type
    Other
    Date Received
    March 31, 2003
    Date of Event
    February 17, 2003
    Report Date
    March 27, 2003
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LAB TECH/CUSTOMER EXPERIENCED A "BLOOD SPLASH" INCIDENT WHILE ANALYZING AN HIV POSITIVE PT SPECIMEN USING A SYSMEX K-1000 HEMATOLOGY ANALYZER. ACCORDING TO THE CUSTOMER, THE BLOOD DROPLET WAS SPLASHED FOR THE TIP OF THE SAMPLING PIPETTE DURING CLEANING OF THE PIPETTE AND LANDED IN THE TECHNICIAN'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX K-1000 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION K-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention