BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1980861 · Received February 7, 2011

    Report

    Report Number
    2939301-2011-01163
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT 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 ORIGINALLY PROVIDED. ON (B)(6) 2011 AT 4:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 568 MG/DL ON THE REPORTED METER. THE PATIENT ADMINISTERED SELF-TREATMENT BASED ON THIS ELEVATED METER READING BY TAKING INSULIN USING HER PUMP. THE PATIENT THEN OBTAINED THE ADDITIONAL BLOOD GLUCOSE READINGS OF 561 MG/DL, 73 MG/DL, 103 MG/DL, 89 MG/DL, 302 MG/DL, 340 MG/DL AND 138 MG/DL ON THE REPORTED METER WITHIN A TIME PERIOD GREATER THAN 20 MINUTES. ONE HOUR LATER, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING AND DIZZINESS. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT HAD NOT PROGRAMMED THE METER FOR THE CORRECT CALIBRATION CODE NUMBER FOR THE LOT OF TEST STRIPS IN USE, WHICH CAN CAUSE INACCURATE READINGS. THE PATIENT HAD NOT PROGRAMMED THE METER WITH THE CORRECT CALIBRATION CODE NUMBER. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening