BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEV

    MDR report key: 1001978 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00219
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA SOFT LANCING DEVICE LANCET DOES NOT FIRE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE PT SAID SHE EXPERIENCED HYPOGLYCEMIA AFTER NOT BEING ABLE TO TEST DUE TO THE LANCING DEVICE BEING BROKEN. SHE DID NOT PROVIDE SPECIFIC DETAILS SUCH AS SYMPTOMS OR TIMING AFTER THE ISSUE BEGAN. THE PT SAID SHE TOOK HER USUAL DOSE OF ORAL DIABETES MEDICATION; THE NAME AND DOSE WERE NOT PROVIDED. THE CCA NOTED THAT THE PT ADMINISTERED SELF TREATMENT OF FOOD AND/OR BEVERAGE. THE CCA NOTED THAT THE PT USED THE LANCING DEVICE ACCORDING TO INSTRUCTIONS. THE LANCING DEVICE WAS REPLACED. THIS COMPLAINT IS REPORTED BECAUSE THE PT ALLEGES THE LFS LANCING DEVICE DID NOT FIRE AND SHE WAS UNABLE TO TEST. AFTERWARDS, SHE CLAIMS SHE EXPERIENCED HYPOGLYCEMIA AND TREATED HERSELF WITH FOOD AND/OR BEVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEV GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R