BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 3183526 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-17998
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH LANCING DEVICE CASING WAS CRACKED OR BROKEN. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTED TAKING NO DIABETES MEDICATIONS TO MANAGE HIS DIABETES AND HE NORMALLY TESTS MORE THAN 4 TIMES A DAY. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 4-5 HOURS AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF ¿BLURRED VISION AND FREQUENT URINATION.¿ THE PATIENT REPORTED HE SELF TREATED WITH 5 UNITS OF FAST ACTING INSULIN. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT REPORTED, DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND RECEIVED TREATMENT ABOVE AND BEYOND HIS NORMAL DIABETES MANAGEMENT ROUTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284256 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R