BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1051907 · Received June 4, 2008

    Report

    Report Number
    2939301-2008-00987
    Event Type
    Injury
    Date Received
    June 4, 2008
    Report Date
    May 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH ULTRA2 IS GIVING ERROR 5 MESSAGES. PER THE OWNER'S MANUAL, ERROR 5 INDICATES THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT. HOWEVER, THE PT WAS UNABLE TO PROVIDE ANY MORE INFO IN REGARDS TO THE INITIAL CALL. THE PT TESTS HIS BLOOD GLUCOSE 3 TIMES PER DAY AND SELF ADJUSTS HIS INSULIN. THE REPORTED ISSUE BEGAN APPROX ONE MONTH PRIOR TO CONTACTED LFS. THE PT STATED HE WENT THROUGH 1 BOX OF 100 TEST STRIPS WHILE ENCOUNTERING THE ERROR 5 MESSAGES. AT SOME POINT AFTER THE REPORTED ISSUE BEGAN, THE PT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SWEATY, NERVOUS, DIZZY, AND BLURRED EYES." AS A RESULT OF THE REPORTED ISSUE, THE PT ALLEGEDLY TOOK GLUCOSE. THE PT DID NOT RECEIVE ANY FURTHER MEDICATION INTERVENTION BECAUSE OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE EVENTS THAT LEAD UP TO THE PT'S REPORTED SYMPTOMS SUCH AS FOOD INTAKE, DIABETES TREATMENT, AND THE LFS METER READINGS. IN ADDITION, IT WOULD ALSO WOULD HAVE BEEN HELPFUL TO KNOW IF THE ERROR 5 MESSAGE WAS INTERMITTENT, WERE THE REPORTED SYMPTOMS INDICATIVE OF BEING HYPOGLYCEMIC OR HYPERGLYCEMIC, WHAT TREATMENT RELIEVED THE PT'S SYMPTOM, AND IF THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY HAS CHANGED SINCE THE INCIDENT. DURING TROUBLESHOOTING, ALTHOUGH THE PT WAS USING THE CORRECT TEST STRIPS AND THE TEST STRIPS WERE IN GOOD CONDITION, THE REPORTED ISSUE WAS NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED HE HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening