BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BLOOD GLUCOSE TEST STRIPS

    MDR report key: 1994904 · Received February 12, 2011

    Report

    Report Number
    MW5019414
    Event Type
    Injury
    Date Received
    February 12, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 12, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE NEW FREESTYLE "BUTTERFLY" TEST STRIPS LOT 1081217 READ 30-50 UNITS LOW WHEN USED WITH OMNIPOD (B)(4) PDM/METER. THIS CAUSES THE PATIENT TO UNDER TREAT HIGH BLOOD SUGAR LEVELS. FREQUENCY: 12 TIMES/DAY. DATES OF USE: (B)(6) 2011. THIS ISSUE MAY BE SPECIFIC TO USING THE NEW STYLE "BUTTERFLY" OF TEST STRIP WITH THE OMNIPOD, OR IT MAY BE A GENERAL PROBLEM WITH THE NEW STYLE OF TEST STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE TEST STRIPS FREESTYLE BLOOD GLUCOSE TEST STRIPS AS USED WITH NBW ABBOTT DIABETES CARE INC 1081217

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| S