BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1844989 · Received November 17, 2008

    Report

    Report Number
    2939301-2008-03095
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATED IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2008 AT 1:46PM, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN/VERIFY ADDITIONAL INFORMATION. THE PT TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH INSULIN (USUALLY REQUIRING NO DOSE ADJUSTMENTS). ON (B)(6) 2008, "AFTER LUNCH", THE PT REPORTEDLY OBTAINED BLOOD GLUCOSE "168 MG/DL" ON THE SUBJECT METER. DUE TO THE READING, SHE CLAIMED THAT SHE TOOK AN ADDITIONAL 4 UNITS OF NOVOLIN R AND AT AN UNSPECIFIED TIME LATER, REPORTEDLY DEVELOPED SYMPTOMS OF "SHAKING, BODY GETS WARM AND HAD GRAYING VISION." AS A RESULT, THE PT CLAIMED THAT SHE ADMINISTERED SELF-TREATMENT WITH FOOD/BEVERAGE AND IT IS UNK WHETHER SHE RETESTED HER BLOOD GLUCOSE AFTER THAT OR WHETHER SHE FELT BETTER. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT THE PT'S NORMAL BLOOD GLUCOSE RANGE IS AND ABOUT WHEN AFTER TAKING INSULIN SHE BEGAN TO DEVELOP THE REPORTED SYMPTOMS. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PT CLAIMED SHE OBTAINED AN ALLEGEDLY INACCURATE HIGH READING ON HER METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED READING AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2845845

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R