BEUDAMED
    FDA Adverse Event Summary report: N

    CHOLESTRAK

    MDR report key: 484054 · Received September 10, 2003

    Report

    Report Number
    MW1029469
    Date Received
    September 10, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 10, 2003
    Manufacturer
    ACCU TECH
    Product Code
    NFX
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER FOLLOWED DIRECTIONS ON BOX. WHEN THEY ATTEMPTED TO USE THE LANCET TO OBTAIN A BLOOD SAMPLE THEY PUSHED AGAINST FINGER, BUT NO NEEDLE CAME OUT OF DEVICE. THE KIT COMES WITH 2 NEEDLES, AND CALLER HAD THE SAME PROBLEM WITH THE 2ND LANCET. CALLER NOTIFIED HELP LINE AS PER DIRECTIONS. LEFT MESSAGE, AND SOMEONE CALLED BACK. THE HELP LINE OFFERED TO REPLACE KIT AND STATED THEY WOULD INCLUDE 2 OLD LANCETS ALONG WITH THE NEW LANCET TO ENSURE DEVICE WOULD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTRAK HOME CHOLESTEROL TESTING KIT NFX ACCU TECH * 03P0242

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR