BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1930890 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10805
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. A 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 11:00AM. IT IS NOT KNOWN WHETHER THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR WHETHER THE PATIENT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN AT THE TIME OF THE ALLEGED ISSUE. AT AN UNSPECIFIED DATE AND TIME, THE PATIENT CLAIMED SHE WAS FEELING SHAKY AND LIGHTHEADED AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO THE SYMPTOMS, IT IS NOT KNOWN WHETHER THE PATIENT RECEIVED ANY MEDICAL TREATMENT AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THIS WAS THE FIRST TIME THE PRODUCTS HAD BEEN USED AND THAT THERE WAS NO MISUSED OF THE PRODUCTS. THE PATIENT WAS NOT ABLE TO TURN THE SUBJECT METER ON WITH THE POWER BUTTON AND STRIP INSERTION PER THE OWNER'S MANUAL. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. 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. 3038522

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening