BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3000954 · Received March 13, 2013

    Report

    Report Number
    3008382007-2013-04808
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 18, 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
    OR, 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 (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN THE EARLY MORNING ABOUT 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "140 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE. A FEW HOURS AFTER, THE PATIENT CLAIMS SHE FELT SWEATY AND CONFUSED (NOT KNOWING WHO OR WHERE SHE WAS). TREATMENT WAS NOT SPECIFIED AT THAT TIME. ON THE MORNING OF (B)(6) 2013, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT "30 POINTS LOWER" THAN THE SUBJECT METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104705 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3057860

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R