BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1955375 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00309
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED BEGAN ON THE EVENING OF (B)(6), 2010. THE PATIENT REPORTED BLOOD RESULTS OF GLUCOSE "80 MG/DL" WITH THE SUBJECT METER AND "43 MG/DL" ON ANOTHER METER (EMERGENCY MEDICAL SERVICE METER), PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. THE PATIENT INDICATED HE WAS NOT TAKING ANY DIABETES MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED 4 HOURS THE ALLEGED ISSUE OCCURRED, HE PASSED OUT. IN RESPONSE TO THE SYMPTOM, THE PATIENT STATED HIS WIFE CALLED EMERGENCY MEDICAL SERVICE (EMS) IMMEDIATELY. ACCORDING TO THE PATIENT, WHEN THE EMS ARRIVED HE WAS TESTED BY THE EMS METER WITH A RESULT OF "43 MG/DL" AND WAS ADMINISTERED IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT AND AN APPROVED SAMPLE SITE WAS USED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 4 HOURS AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2947020

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R