BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1212115 · Received October 24, 2008

    Report

    Report Number
    2939301-2008-02783
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER HAS A BATTERY INDICATOR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND RECORDED PHONE CONVERSATION. THE PATIENT TESTS HER BLOOD GLUCOSE 8-10 TIMES A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT STATED THAT THE BATTERY INDICATOR ISSUE OCCURRED ABOUT THREE MONTHS AGO AND SOMETIME AFTER THE METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATY, FAST HEARTBEAT, LIGHTHEADED, DIZZY AND SHAKY. IT WAS NOT KNOWN IF THE PATIENT OBTAINED ANY OTHER READINGS ON THE SUBJECT METER. THE PATIENT THEN STATED THAT SHE USED HER FRIEND'S METER (AROUND THE SAME TIME) AND THE RESULTS WAS "62 MG/DL." AS A RESULT OF THE REPORTED SYMPTOMS, SHE CALLED HER HEALTHCARE PROFESSIONAL (HCP_ AND WAS REPORTEDLY ADVISED,"TO NOT PANIC AND TAKE SOME ORANGE JUICE." THERE WAS NO OTHER MEDICAL TREATMENT MENTIONED AT THIS TIME. THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THERE WAS NO METER TRAUMA. THE BATTERY WAS REPLACED ACCORDING TO THE OWNER MANUAL'S INSTRUCTIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED METER ISSUE STARTED. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2822434

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization