BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4141833 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33658
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    November 20, 2013
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED 1 OPENED/USED ENLITE SENSOR AND PERFORMED VISUAL INSPECTION AND FAILED PER SPECIFICATIONS. FOUND CANNULA BENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SENSOR GOT SPLIT IN HALF. CUSTOMER STATED THAT ON THE 4TH DAY OF WEARING THE SENSOR IT STARTED TO ITCH; SHE REMOVED IT AND IT WAS BENT THREE TIMES AND SPLIT. CUSTOMER INSERTS IN ABDOMEN AND HAS NO SCAR TISSUE. BLOOD GLUCOSE VALUE IS 130 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621712 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A J113U

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR