BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2082315 · Received May 9, 2011

    Report

    Report Number
    2939301-2011-03803
    Event Type
    Injury
    Date Received
    May 9, 2011
    Report Date
    April 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNUSUAL ISSUE WITH HER ONETOUCH ULTRALINK METER DISPLAYING "79" WITH NO ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. A COUPLE DAYS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE PASSED OUT. A HOME HEALTH/VISITING NURSE GAVE THE PATIENT HONEY UNDER THE TONGUE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3059757

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R