BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2103151 · Received May 25, 2011

    Report

    Report Number
    2939301-2011-04383
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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#: K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/REPORTER, THE PATIENT'S MOTHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK 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) 2011 AT 9:20 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 175 MG/DL AND 173 MG/DL ON THE REPORTED METER. FIVE MINUTES AFTERWARDS, THE PATIENT PASSED OUT. EMERGENCY SERVICES WERE CONTACTED. WHEN PARAMEDICS ARRIVED, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED TO BE "LESS THAN 40 MG/DL". THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE PATIENT MANAGES HIS DIABETES USING AN INSULIN PUMP. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED METER READINGS ON THE REPORTED METER, AND RECEIVED EMERGENCY MEDICAL ATTENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3071688

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R