BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1837160 · Received September 16, 2010

    Report

    Report Number
    2939301-2010-08041
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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.510K: K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 8:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 317 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY HIGH. THE PATIENT TOOK THE ACTION OF CONSUMING LESS FOOD AND/OR DRINK. AFTERWARDS, HE EXPERIENCED THE SYMPTOM OF COLD SWEATS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE CONSUMED LESS FOOD BASED ON AN ELEVATED METER READING. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2982031

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening