BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 2030590 · Received March 24, 2011

    Report

    Report Number
    MW5019916
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    LIFESCAN
    Product Code
    FMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE TOUCH LANCING DEVICE (ONETOUCH ULTRA SOFT) WITH SPRING MECHANISM BRUISES SKIN. BOTH FOREARMS OF PT BRUISED. PT HAS AFIB, IS TAKING ANTICOAGULANT (WARFARIN OR PRADAXA) THAT MAKES PT PRONE TO BRUISING. PT IS DIABETIC. DISCONTINUANCE OF BLOOD SUGAR TESTING IS AGAINST MEDICAL ADVICE. CONTINUED BLOOD SUGAR TESTING WILL CAUSE SUBSTANTIAL BRUISING. STANDARD PRACTICE IS BLOOD SUGAR TEST WITH LANCING DEVICE 4 - 6 TIMES PER DAY. NONINVASIVE GLUCOSE METER ARE NOT AVAILABLE YET. MOST IF NOT ALL LANCING DEVICES WILL CAUSE BRUISING TO ALL BRUISING PRONE PTS AND ALSO CURRENT GENERATION OF LANCING DEVICES MITIGATE COMPLIANCE WITH MEDICAL ADVICE FOR BLOOD SUGAR TESTING DUE TO PAIN AND BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH LANCING DEVICE FOR BLOOD GLUCOSE METER FMK LIFESCAN ONETOUCH NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention