BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1082178 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01500
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 21, 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 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    ON JULY 21, 2008, A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT ON ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT TESTS HIS BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HIS DIABETES WITH PILLS, DIET AND EXERCISE. A WEEK EARLIER IN THE EVENING TIME, THE PATIENT ALLEGED THAT THE METER WOULD NOT POWER ON. AS A RESULT OF THE ALLEGED METER ISSUE, HE REPORTEDLY TOOK NO ACTIONS TOWARDS HIS DIABETES ROUTINE. SOMETIME AFTER THE ALLEGED ISSUE, THE PATIENT MENTIONED THAT HE DEVELOPED SYMPTOMS OF "FREQUENT URINATION" AND REPORTEDLY DID NOT SEEK MEDICAL INTERVENTION OR RECEIVED ANY TREATMENTS. IT WAS UNKNOWN WHETHER THE PATIENT TREATED HIMSELF DUE TO THE REPORTED SYMPTOMS. HOWEVER, THE PATIENT DID MENTION THAT HE WAS TESTING ON A BACKUP METER AND OBTAINED A "109 MG/DL" AT AN UNSPECIFIED TIME OR DATE. AT THE TIME OF TROUBLESHOOTING, THE FOLLOWING WAS VERIFIED BY THE CSR: THERE WAS NO MISUSE OF THE PRODUCT AND THE PATIENT WAS USING THE CORRECT TEST STRIPS TO TEST THE METER WITH. THE METER POWERED ON WHEN THE POWER BUTTON WAS PRESSED AND WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. ALTHOUGH THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. 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 2706451

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening