BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1820359 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07340
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON AFTER IT HAD BEEN DROPPED; SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT NOTED SHE HAD A LOW APPETITE AND WAS NOT EATING MUCH FOOD. THE PATIENT ADMINISTERED SELF-TREATMENT WITH SODA AND HONEY AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH INSULATARD INSULIN 50 UNITS IN THE MORNING AND 30 UNITS IN THE EVENING. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT AND THE PATIENT HAD CORRECTLY REPLACED THE METER'S BATTERY. THE ISSUE WAS NOT RESOLVED. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE THOSE SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2963805

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R