BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SAFE T-PRO

    MDR report key: 2144475 · Received June 23, 2011

    Report

    Report Number
    2144475
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    February 7, 2009
    Report Date
    February 17, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    ACCU-CHEK SAFE T-PRO LANCET WAS GOING TO BE USED TO CHECK PATIENT'S BLOOD SUGAR. WHEN THE STAFF TWISTED OFF THE "BLUE TOP" PLASTIC PIECE, THE ENTIRE NEEDLE CAME OUT AND WAS EXPOSED, AND STAFF MEMBER PUNCTURED HER FINGER WITH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SAFE T-PRO SINGLE USE LANCET FMK ROCHE DIAGNOSTICS NDC NO. 50924-951-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *