BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3895868 · Received June 26, 2014

    Report

    Report Number
    2939301-2014-15457
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER DISPLAYED A ¿STRIP ISSUE¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2014. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HER DIABETES AND CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF SWEATY. THE PATIENT TREATED HERSELF WITH FOOD AND/ OR DRINK. THE PATIENT DID NOT TEST HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE REPORTED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374918 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3581175

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R