BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243946 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03263
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION 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 POWERS OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN/VERIFY ADDITIONAL INFORMATION. THE PATIENT NORMALLY TESTS 5-6 TIMES DAILY AND MANAGES HER DIABETES WITH PILLS (GLUCOPHAGE AND GLYBURIDE), DIET AND EXERCISE. BEFORE THE METER ISSUE OCCURRED TWO DAYS PRIOR TO ORIGINAL DATE AT AROUND 10:00 AM, HER BLOOD GLUCOSE READING ON THE SUBJECT METER WAS "165 MG/DL." AS A RESULT, THE PATIENT REPORTEDLY SKIPPED HER NORMAL MEAL BECAUSE SHE DID NOT WANT TO GET HIGH BLOOD GLUCOSE. SOMETIME AFTER THE ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATY AND VERTIGO BUT DID NOT RECEIVE ANY TREATMENT. LATER IN THE NIGHT, THE METER GAVE A READING AND IT WAS REPORTED AS LOW "52 MG/DL." THE PATIENT CLAIMED THAT SHE WAS THEN COMFORTABLE TO EAT AND TAKE HER REGULAR MEDICATION. THE PATIENT DID NOT REPLACE THE METER'S BATTERY PER THE OWNER'S MANUAL AND DOES NOT HAVE A REPLACEMENT BATTERY. THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THERE WAS NO METER TRAUMA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2815618

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening