BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1173430 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02359
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONE TOUCH ULTRA2 METER HAS A BACKLIGHT ISSUE. ACCORDING TO THE PT, THE BACKLIGHT ISSUE FIRST OCCURRED IN THE MORNING BEFORE THE PT WENT TO THE DOCTOR ON FOUR DAYS EARLIER. THE PT REPORTEDLY DID NOT HAVE ANY SYMPTOMS BEFORE, DURING, OR AFTER THE REPORTED ISSUE BEGAN. THE PT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "130 MG/DL" ON THE DOCTOR'S METER AND WAS TREATED WITH INSULIN (20 UNITS OF HUMLIN AND 3 UNITS REGULAR INSULIN). IT IS NOT KNOWN WHY THE PT WAS TREATED WITH INSULIN, AS THE PT DID NOT HAVE ANY SYMPTOMS AND DID NOT OBTAINED AN ELEVATED READING. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS NOT RESOLVED. THE PT DID NOT REPLACE THE METER'S BATTERY PER THE OWNER'S MANUAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE RECEIVED TREATMENT THAT SUGGEST THE PT WAS HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2733537

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R