BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH VITA METER

    MDR report key: 1192402 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02540
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 29, 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.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. ON OCT. 1, 2008, THE TECHNICAL SERVICE REP (TSR) SPOKE WITH THE PT TO OBTAIN AND VERIFY INFO. ON TWO DAYS PRIOR TO ORIGINAL DATE, AT 11:00 PM, THE PT REPORTEDLY OBTAINED THE BLOOD GLUCOSE READING OF 274 MG/DL ON THE REPORTED METER, WHICH WAS HIGH COMPARED TO HER EXPECTED VALUES. THE PT HAD BEEN USING THIS PLASMA-CALIBRATED METER FOR A FEW DAYS; HER PREVIOUS METER WAS A WHOLE BLOOD-CALIBRATED METER (ONE TOUCH BASIC). AT THAT TIME, THE PT WAS NOT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. BASED ON THIS READING, THE PT TOOK SEVEN UNITS HUMINSULIN INSULIN. ON THE NEXT DAY AT 3:00AM, THE PT AWOKE ALLEGEDLY EXPERIENCING THE SYMPTOMS OF SWEATING AND NAUSEA. SHE DID NOT TEST HER BLOOD GLUCOSE LEVEL WHILE SYMPTOMATIC. THE PT ADMINISTERED SELF-TREATMENT BY TAKING GLUCOSE AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK ANY MEDICAL ATTENTION. EARLIER ON THE DAY OF THE EVENT (7:30 AM) THE PT HAD OBTAINED A FASTING BLOOD GLUCOSE READING OF 102 MG/DL, AND TOOK THREE UNITS HUMINSULIN INSULIN. THE PT HAD EATEN HER NORMAL MEALS DURING THE DAY, ALTHOUGH AT LATER THAN USUAL TIMES. THE PT TAKES HUMINSULIN INSULIN THREE UNITS IN THE MORNING AND SIX TO SEVEN UNITS IN THE EVENING, ADJUSTING THESE DOSES BASED ON METER READINGS. THE PT TESTS TWICE PER DAY, AND WAS UNABLE TO STATE HER EXPECTED VALUES. THE PT WAS NOT AWARE OF THE 10% TO 12 % HIGHER VALUES OBTAINED WITH PLASMA-CALIBRATED METERS VERSUS WHOLE BLOOD-CALIBRATED METERS. HER TARGET VALUES HAD NOT BEEN ADJUSTED DUE TO THE USE OF THE NEW METER. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE PT'S TESTING TECHNIQUE WAS CORRECT AND THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PT ALLEGED SHE DID NOT UNDERSTAND THE PLASMA-CALIBRATED READINGS ON THE REPORTED METER WOULD BE HIGH COMPARED TO HER PREVIOUS WHOLE BLOOD-CALIBRATED METER, AND TOOK AN INSULIN DOSE BASED ON THIS READING. THE PT EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND RECEIVED SELF-TREATMENT WITH GLUCOSE TO RESOLVE THOSE 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 VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R