BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3150876 · Received June 6, 2013

    Report

    Report Number
    3008382007-2013-15635
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 20, 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
    MS, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT 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 PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 6:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 222 MG/DL, 277 MG/DL AND 196 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WERE INACCURATELY HIGH COMPARED TO HER EXPECTED VALUES. AT THAT TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF SEVERE HYPOGLYCEMIA EARLY IN THE MORNING, AND WHILE SYMPTOMATIC OBTAINED METER READINGS THAT WERE ELEVATED, AND RECEIVED TREATMENT WITH GLUCOSE TO ALLEVIATE HER SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251225 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3322021

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R