BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1192397 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02545
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    May 10, 2008
    Report Date
    September 30, 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 EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM. GENDER: MALE.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT IN GERMANY CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS COMPARED TO HIS EXPECTED VALUES. ON THE NEXT DAY, THE TECHNICAL SVCS REP (TSR) SPOKE WITH THE PT TO OBTAIN AND VERIFY INFO. THE PT STATED HE HAS EXPERIENCED SEVERAL HYPOGLYCEMIC EVENTS DURING THE PAST THREE MONTHS. ON FIVE MONTHS EARLIER AT NOON, THE PT REPORTEDLY BECAME UNCONSCIOUS. THE PT WAS UNABLE TO CONFIRM IF HIS BLOOD GLUCOSE LEVEL WAS TESTED USING THE REPORTED METER WHILE HE WAS UNCONSCIOUS. THE PT'S SON CONTACTED EMERGENCY SERVICES. PARAMEDICS ARRIVED, AND TESTED THE PT'S BLOOD GLUCOSE LEVEL TO BE 1.6 MMOL/L (29 MG/DL). HE WAS TREATED WITH A GLUCAGON INJECTION. THE PT WAS NOT TRANSPORTED TO THE HOSP. EARLIER ON THE DAY OF THIS EVENT, THE PT HAD EATEN HIS NORMAL BREAKFAST. THE PT WAS UNABLE TO PROVIDE ANY METER READINGS OR INSULIN DOSES TAKEN THAT MORNING. THE PT REPORTEDLY TAKES NOVORAPID INSULIN BASED ON METER READINGS, AND INSUMAN BASAL INSULIN EIGHT TO TWELVE UNITS TWICE PER DAY. THE PT TESTS HIS BLOOD GLUCOSE LEVEL FOUR TIMES PER DAY. HE HAS NO BACKUP METER. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE PT'S TESTING TECHNIQUE WAS CORRECT, THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING, AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE AND CALIBRATION CODE NUMBER. QC TESTING WAS PERFORMED, WITH TWO FAILING RESULTS, OUT OF RANGE HIGH. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PT ALLEGEDLY BECAME UNCONSCIOUS FOLLOWING AN INSULIN DOSE WHICH WAS TAKEN BASED ON THE REPORTED METER'S READINGS, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCAGON. THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2830636

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R