BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1133250 · Received August 21, 2008

    Report

    Report Number
    2939301-2008-01916
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT IN GERMANY CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA METER WAS GIVING INACCURATELY HIGH READINGS. ON AUGUST 19, 2008, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON NINE DAYS PRIOR TO ORIGINAL DATE AT 1:30 PM, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF 140 MG/DL ON THE REPORTED METER. THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL PRIOR TO DRIVING HER CAR. AT THAT TIME, THE PATIENT WAS EXPERIENCING NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. BASED ON THIS READING, ACCORDING TO HER SLIDING SCALE REGIMEN, THE PATIENT TOOK ONE UNIT HUMALOG INSULIN. EARLIER ON THIS DAY, AT 6:00 AM, THE PATIENT HAD EATEN BREAKFAST AND TAKEN TWO UNITS HUMALOG INSULIN. THE PATIENT HAD TESTED HER BLOOD GLUCOSE LEVEL EARLIER THAT DAY, BUT WAS UNABLE TO PROVIDE THE READINGS. AT 2:00 PM, WHILE AT HER SISTER'S HOME, THE PATIENT EXPERIENCED THE SYMPTOMS OF CONFUSED SPEECH AND DIFFICULTY REMEMBERING. WHILE SYMPTOMATIC, THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL USING HER SISTER'S METER, AND REPORTEDLY OBTAINED THE READING OF 29 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD, AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK MEDICAL ATTENTION. THE PATIENT TAKES HUMALOG INSULIN ON A SLIDING SCALE BASED ON MEALS AND METER READINGS, AND 38 UNITS OF LANTUS PER DAY. THE PATIENT TESTS HER BLOOD GLUCOSE LEVEL FIVE TIMES PER DAY, AFTER MEALS. THE TSR DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, AND THE FOLLOW UP CALL, THAT THE PATIENT'S TEST STRIPS WERE WITHIN OPENED EXPIRATION DATING, HER TESTING TECHNIQUE WAS CORRECT, AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER TAKING AN INSULIN DOSE ON THE ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD TO RESOLVE THE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R