BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3203258 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18868
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND; THE COMPLAINT WAS NOT REPRODUCED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/REPORTER, THE PATIENT¿S MOTHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 428 MG/DL AND 178 MG/DL ON THE REPORTED METER OVER A TIME PERIOD GREATER THAN 20 MINUTES. THE PATIENT TOOK NO ACTIONS DUE TO THE METER READINGS. AT AN UNSPECIFIED TIME AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING AND TESTED POSITIVE FOR LARGE AMOUNTS OF KETONES. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED METER READINGS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302357 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3361723

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening