BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1118358 · Received August 14, 2008

    Report

    Report Number
    2939301-2008-01887
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 8, 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 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 PATIENT/LAY PERSON CONTACTED LFS AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WOULD NOT POWER ON AROUND 8PM ON FIVE DAYS PRIOR TO ORIGINAL DATE DESPITE HAVING CHANGED THE BATTERIES. REPORTEDLY BEFORE THE ALLEGED ISSUE, THE PATIENT EXPERIENCED TINGLING IN HIS HAND, AND ON THREE DAYS PRIOR TO ORIGINAL DATE, HE WAS INJECTED WITH INSULIN IN THE CLINIC. BECAUSE THE ISSUE COULD NOT BE RESOLVED, CUSTOMER SERVICE REPLACED THE PRODUCT. THIS SENIOR MEDICAL AFFAIRS SPECIALIST, WHO SPOKE WITH THE PATIENT ON FIVE DAYS AFTER THE ORIGINAL DATE, HAS CLASSIFIED THE COMPLAINT BASED UPON HIS INFORMATION. THE PATIENT REPORTED THE FOLLOWING: THE PATIENT SAID THAT BECAUSE HIS METER WOULD NOT TURN ON HE HAD NOT BEEN ABLE TO TEST SINCE APPROXIMATELY FIVE DAYS PRIOR TO ORIIGNAL DATE. HIS DOCTOR DETERMINED THE TINGLING IN HIS HAND WAS ASSOCIATED WITH NEUROPATHY. ALTHOUGH THE PATIENT CONTINUED TAKING HIS ORAL DIABETIC MEDICATION, HE "COULD NOT" TAKE HIS NOVOLIN "BECAUSE IT IS ON A SLIDING SCALE", HE SAID. ON THREE DAYS PRIOR TO ORIGINAL DATE, THE PATIENT WAS SEEN IN HIS VA CLINIC FOR A REGULAR SCHEDULED APPOINTMENT. AFTER A RESULT OF 173 MG/DL WAS REPORTEDLY OBTAINED ON THE DOCTOR'S METER, THE DOCTOR INJECTED THE PATIENT WITH 8 UNITS OF NOVOLIN. THE PATIENT IS NOW SUCCESSFULLY USING HIS REPLACEMENT METER. THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT BECAUSE THE PATIENT ALLEGED HE COULD NOT TAKE HIS DAILY SLIDING SCALE DUE TO THE REPORTED POWER ISSUE AND A FEW DAYS LATER WAS TREATED WITH INSULIN BY HIS PHYSICIAN IN THE CLINIC. DAILY REGIME. ORAL MEDICATION NAME NOT PROVIDED. NOVOLIN: 0-150, 2U; 151-200, 4U; 201-250, 5U; 251-300, 6U; 301-400, 8U; >400 GO TO ER OR TO CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2819783

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R