BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1192404 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02548
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE 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

    IN 2008, AT 8:01 AM, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER "DOES NOT TURN ON." THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN/VERIFY ADDITIONAL INFO. THE PATIENT TESTS HER BLOOD GLUCOSE 3-4 TIMES A DAY AND TAKES INSULIN WITH DIET AND EXERCISE TO MANAGE HER DIABETES. THE PT CURRENTLY TAKES 5-10 UNITS OF HUMALOG TWICE A DAY AND 35 UNITS OF LANTUS ONCE AT NIGHT BEFORE GOING TO SLEEP. THE PT STATED TO THE MAS THAT THE SUBJECT METER WAS DROPPED INTO THE WATER ON THE DAY BEFORE AT AROUND 3PM. AS A RESULT, THE PT DID NOT MAKE ANY CHANGES IN REGARDS TO HER DIABETES REGIMEN AND CLAIMED THAT SHE CONTINUED TO WATCH HER DIET TO MANAGE HER DIABETES. THAT EVENING, THE PT CLAIMED THAT SHE TOOK 6 UNITS OF HUMALOG AT 7:30 PM AND 35 UNITS OF LANTUS AT 10 PM (USUAL DOSAGE) AND DID NOT MAKE ANY CHANGES IN REGARDS TO HER DIET AND/OR EXERCISE. THE NEXT MORNING AT 5 AM, THE PT REPORTEDLY HAD AN INSULIN REACTION WHERE SHE STATED FEELING "SWEATY, SHAKING AND HARD TO GET UP." THE PT STATED THAT SHE ATE A FEW "SPOONFULS" OF PEANUT BUTTER WITH WATERMELON AND REPORTEDLY FELT BETTER WITHIN 20 MINUTES. INCLUDING THIS EVENT, THE PT STATED THAT THIS WOULD BE THE SECOND TIME SHE HAS HAD THE SAME EPISODE. THE LAST TIME, THE PT MENTIONED BEING SEEN AT THE HOSPITAL AND HER BLOOD GLUCOSE WAS "30 MG/DL." THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE WAS NOT ABLE TO TEST HER BLOOD GLUCOSE ON THE LFS PRODUCT AFTER IT WAS DROPPED INTO THE WATER (USE ERROR). SHE STATED THAT AFTERWARD SHE EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AND FELT BETTER AFTER EATING FOOD. 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 2788134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R