BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4233539 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48799
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 3 OPENED/USED ENLITE SENSOR AND PERFORMED VISUAL INSPECTION AND FOUND ALL 3 SENSOR CANNULA BENT. UNABLE TO CONFIRM CUSTOMER RECEIVED SENSORS IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED/USED.

    Description of Event or Problem · 1

    WHILE REPORTING ISSUES WITH BENT SENSORS, CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL AROUND 40 MG/DL. BLOOD GLUCOSE LEVEL WAS 77 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715744 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR