BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4213486 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37231
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 1 OPENED/USED SENSOR AND PERFORMED A VISUAL INSPECTION AND FOUND BENT ELECTRODE, SENSOR FAILED PER INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS SENSOR WAS BENT DURING INSERTION INTO HIS BODY. CUSTOMER'S BLOOD GLUCOSE WAS UNK. THE CUSTOMER WAS ADVISED HIS SENSOR WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647402 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR