BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2025449 · Received March 21, 2011

    Report

    Report Number
    2939301-2011-02379
    Event Type
    Injury
    Date Received
    March 21, 2011
    Report Date
    March 2, 2011
    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER HAD A BLURRED DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF STRESS AND THIRSTY. THE REPORTER DENIED THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED IT WAS NOT THE FIRST TIME THE SUBJECT METER WAS BEING TESTED WITH AND THERE WAS NO MISUSE OF THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening