BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2013463 · Received March 10, 2011

    Report

    Report Number
    2939301-2011-02043
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 24, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SLEEPY, CONFUSED, HAD BLURRED VISION AND "ALMOST FAINTED." THE PATIENT DID NOT SPECIFY TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER HAD GOTTEN WET FROM THE RAIN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3075209

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening