BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2472726 · Received February 29, 2012

    Report

    Report Number
    2939301-2012-02047
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT WAS FOUND TO HAVE THE BATTERY INDICATOR ON, BUT CONFIRMED THE METER WAS WORKING PROPERLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE 510(K) # IS K0611183.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 12:30PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "304 AND 513 MG/DL" WITH THE SUBJECT METER PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON INSULIN. DUE TO THE ALLEGED ISSUE, THE PATIENT INDICATED SHE RESPONDED TO EATING MORE FOOD/DRINK BETWEEN 1:00PM AND 1:30PM THAT DAY. HALF AN HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STATED SHE PASSED OUT. IN RESPONSE TO THE SYMPTOM, THE PATIENT REPORTED EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED FOR ASSISTANCE. WHEN THE EMS ARRIVED, THE PATIENT CLAIMED SHE WAS TESTED BY THE EMS METER AND OBTAINED A READING OF "20 MG/DL" AND WAS THEN ADMINISTERED GLUCOSE TABLETS/GLUCOSE GEL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, AN APPROVED SAMPLE SITE WAS USED, AND THE PATIENT'S PROCESS FOR TESTING CORRECT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND WAS TREATED BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3210790

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R