BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1222079 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02934
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 19, 2008
    Report Date
    October 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER HAVING A BATTERY INDICATOR ISSUE. ON THE SAME DAY BETWEEN 3 AND 4PM, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "SHAKINESS" AFTER THE BATTERY INDICATOR ISSUE FIRST OCCURRED. THE PATIENT REPORTEDLY COULD NOT OBTAIN A BLOOD GLUCOSE READING AT THE TIME OF CONCERN. HOWEVER, THE PATIENT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AND DID NOT RECEIVE ANY MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. IN ADDITION, THE PATIENT DID NOT TEST ON ANY OTHER DEVICE AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, AND THE EVENTS LEADING UP TO THE PATIENT'S MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE BATTERY INDICATOR ISSUE WAS NOT RESOLVED ALTHOUGH THE BATTERY WAS REPLACED PER THE OWNER'S MANUAL, AND THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE BATTERY INDICATOR ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2849540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening