BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1955431 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00321
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    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

    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'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S 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'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 10:00AM. THE REPORTER PROVIDED BLOOD GLUCOSE RESULTS OF "96 MG/DL" WITH THE SUBJECT METER AND "26 MG/DL" ON ANOTHER METER (EMERGENCY MEDICAL SERVICE METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE REPORTER INDICATED THAT THE PATIENT MANAGES HER DIABETES INSULIN. FORTY-FIVE MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT RESPONDED TO EATING MORE FOOD AND/OR DRINK. THE REPORTER STATED ½ AN HOUR BEFORE THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF DIZZINESS, LIGHTHEADEDNESS, AND WAS UNABLE TO COMMUNICATE. ACCORDING TO THE REPORTER, AT AN UNKNOWN TIME, THE PATIENT WAS ADMINISTERED IV GLUCOSE AS TREATMENT BY THE EMS ON THE WAY TO THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULT FROM THE SUBJECT METER AND THE CORRECT UNIT OF MEASURE WAS SET CORRECTLY. THE REPORTER STATED THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S REPORTER CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER AND REPORTEDLY REQUIRED HCP INTERVENTION 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. 3068995

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention