BEUDAMED
    FDA Adverse Event Summary report: N

    OT ULTRALINK METER

    MDR report key: 3811642 · Received May 15, 2014

    Report

    Report Number
    2939301-2014-11363
    Date Received
    May 15, 2014
    Report Date
    May 9, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THE ULTRALINK METER HAS A DISPLAY ISSUE (DAMAGE SCREEN AND BLACK MARKS) AND POWER ISSUE (DOES NOT TURN ON). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT¿S DIABETES IS MANAGED WITH AN INSULIN PUMP. THE DISPLAY AND POWER ISSUE BEGAN ON (B)(6) 2014 DURING THE MORNING TIME. THE PATIENT DID NOT MANAGE HIS DIABETES BASED ON THE LFS METER READINGS THAT DAY. LATER THAT EVENING TIME, THE PATIENT REPORTEDLY TESTED ON ANOTHER METER AT ¿33 MG/DL¿ AND HAD SYMPTOMS OF ¿HEADACHE, SHAKY, COLD SWEATS, AND TIRED.¿ SHE WAS ABLE TO ADMINISTER SELF TREATMENT WITH GLUCAGON INJECTION. THE DISPLAY AND POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO PRODUCT MISUSE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED TREATMENT FOR HYPOGLYCEMIA AFTER THE PRODUCT ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291619 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3595454

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R