BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2504590 · Received March 26, 2012

    Report

    Report Number
    2939301-2012-02939
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    March 18, 2012
    Report Date
    March 23, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE 510K #K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH ULTRA2 METER WILL NOT POWER ON AFTER SHE DROPPED HER METER IN WATER. THE PATIENT CLAIMED THE SUBJECT METER DISPLAY HAD LINES CROSS IT BEFORE IT NO LONGER POWERED ON . SUBSEQUENTLY, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE AND DEVELOPED LOW BLOOD GLUCOSE SYMPTOMS DESCRIBED AS "SHAKY AND SWEATY." DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE IDENTIFIED THE ISSUE AS A PRODUCT MISUSE. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USE ERROR AND BECAUSE, THE PATIENT DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF ACUTE COMPLICATIONS OF DIABETES AFTER THE PATIENT ALLEGEDLY COULD NOT TEST ON THE SUBJECT METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening