BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1032813 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00595
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT IN ANOTHER COUNTRY CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WOULD POWER OFF DURING USE, FOLLOWING A BATTERY REPLACEMENT. ON THE FOLLOWING DAY, THE TECHNICAL SERVICE REP (TSR) SPOKE WITH THE PT TO OBTAIN AND VERIFY INFORMATION. ON FOUR DAYS PRIOR TO ORIGINAL DATE, THE PT REPLACED THE BATTERY IN THE REPORTED METER; FOLLOWING THIS, THE METER WOULD POWER OFF DURING USE. SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE RESULT. BECAUSE SHE COULD NOT TEST HER BLOOD GLUCOSE LEVEL, THE PT DECREASED HER INSULIN DOSES. THE PT TOOK 16 UNITS INSTEAD OF 18 UNITS MIXTARD INSULIN IN THE MORNING, AND 14 UNITS INSTEAD OF 16 UNITS IN THE EVENING. THE PT TAKES MIXTARD INSULIN TWICE PER DAY, ADJUSTING THE DOSE BASED ON METER READINGS AND MEALS. ON ORIGINAL DATE AT 7:00 AM, THE PT EXPERIENCED THE SYMPTOM OF LIGHTHEADEDNESS AND FELT HYPOGLYCEMIC. THE PT ADMINISTERED SELF-TREATMENT WITH FOOD, EATING TOAST WITH BUTTER AND MARMALADE. SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE TSR DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THAT THE PT HAD REPLACED THE BATTERY ACCORDING TO MANUFACTURER'S RECOMMENDATIONS, THE BATTERY CONTACTS WERE IN GOOD CONDITION, AND THERE HAD BEEN NO MISUSE OF THE METER. THE PT DID NOT HAVE A BACKUP METER. THE METER WAS REPLACED. THE PT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS, NOT ADJUST HER INSULIN DOSES BASED ON HER SLIDING SCALE, DUE TO THE POWER ISSUE ON THE REPORTED METER. THE PT ALLEGEDLY BECAME HYPOGLYCEMIC 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2800924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R