BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SAFE-T-PRO

    MDR report key: 3807184 · Received May 5, 2014

    Report

    Report Number
    3807184
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    FACET TECHNOLOGIES, LLC
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE CHECKING BLOOD SUGAR, THE LANCET NEEDLE FAILED TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268099 ACCU-CHEK SAFE-T-PRO LANCET NEEDLE FMK FACET TECHNOLOGIES, LLC 03136752001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *