BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC METER

    MDR report key: 1060284 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01054
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    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/PT IN ANOTHER COUNTRY CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH BASIC METER WAS POWERING OFF DURING TESTING. ON JUNE 6, 2008, THE TECHNICAL SERVICE REP SPOKE WITH THE PT TO OBTAIN AND VERIFY INFORMATION. SINCE THE END OF THE PRREVIOUS MONTH, THE PT NOTED THE REPORTED METER WOULD POWER OFF DURING TESTING; SHE WAS UNABLE TO OBTAIN A READING. ON TWO DAYS LATER AT 3:00 AM, THE PT AWOKE REPORTEDLY EXPERIENCING THE SYMPTOMS OF WEAKNESS AND SHE 'FELT SICK'. THE PT ATTEMPTED TO TEST HER BLOOD GLUCOSE LEVEL USING THE REPORTED METER; HOWEVER, THE METER POWERED OFF AND SHE DID NOT OBTAIN A RESULT. THE PT CONTACTED HER SON, WHO ARRIVED AT 4:00 AM. THE PT'S SON TESTED HER BLOOD GLUCOSE LEVEL TO BE APPROXIMATELY 2.0 MMOL/L (36 MG/DL) USING THE PATIENT'S ONE TOUCH ULTRA EASY METER. THE PT WAS TREATED WITH TEA AND SUGAR, AND SHE FELT BETTER AFTERWARDS. THE PT'S PHYSICIAN WAS CONTACTED, AND HE ARRIVED AT 5:00 AM. THE PT RECEIVED NO TREATMENT. THE PT TESTS HER BLOOD GLUCOSE LEVEL TWICE PER DAY. SHE WAS UNABLE TO PROVIDE HER EXPECTED READINGS OTHER THAN TO STATE THEY ARE 'VARIED'. THE PT TAKES THE SET DOSES OF INSULATE INSULIN 40 UNITS AT BREAKFAST AND 25 UNITS AT DINNER. ON THE DAY PRIOR TO THE EVENT, ON TWO DAYS BEFORE, THE PT HAD TAKEN HER USUAL MEALS AND MEDICATIONS, AND HAD REPORTEDLY EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT WAS UNABLE TO PROVIDE ANY INFO AS TO HER ACTIONS DURING THE REPORTED HYPOGLYCEMIC EVENT, AFTER THE USE OF THE METER. THE PT HAS TWO ADDITIONAL METERS, BUT DID NOT UNDERSTAND HOW TO USE THEM TO TEST HER BLOOD GLUCOSE LEVELS. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE PT HAD NOT REPLACED THE METER'S BATTERY ACCORDING TO MFR'S RECOMMENDATIONS. THE OWNER'S BOOKLET STATES THE EXPECTED BATTERY LIFE IS APPROXIMATELY ONE YEAR. THE BATTERY WAS REPLACED. THE PT DID NOT REPLACE THE METER'S BATTERY AS RECOMMENDED. THE PT WAS REPORTEDLY UNABLE TO TEST HER BLOOD GLUCOSE LEVEL FOR TWO DAYS. THE PT CLAIMED SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL. IT IS UNK IF THE PT'S SYMPTOMS WORSENED PRIOR TO OBTAINING A READING OF 2.0 MMOL/L AND RECEIVING TREATMENT. THEREFORE, THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R