BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU CHEK SAFE T PRO

    MDR report key: 4619875 · Received March 6, 2015

    Report

    Report Number
    4619875
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 6, 2015
    Manufacturer
    FACET TECHNOLOGIES, LLC
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CARE TECHNICIAN (PCT) WAS GOING TO DO A BLOOD SUGAR ON A PATIENT. WHEN SHE REACHED INTO THE CART TO GRAB THE LANCET, SHE NOTICED THE LANCET WAS FAULTY. THERE WAS METAL HANGING OUTSIDE OF THE LANCET AS IF THE SPRING WAS BROKEN WITH METAL EXPOSED. THERE WAS NO HARM TO THE PCT OR PATIENT. THE LANCET WAS REMOVED FROM PATIENT CARE AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157369 ACCU CHEK SAFE T PRO LANCET, BLOOD FMK FACET TECHNOLOGIES, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *