BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4173581 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38605
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED 2 OPENED/USED ENLITE-SENSORS AND PERFORMED VISUAL INSPECTION AND FAILED PER SPEC. FOUND CANNULA BENT. CANNOT TEST OR REPRODUCE SKIN IRRITATION, ALSO UNABLE TO PERFORM INSERTION TEST DUE TO ENLITE-SENSORS BEING OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PROBLEMS WITH HER SENSORS. SHE STATED THAT HER SENSORS SEEM TO DIE QUICKLY AND THAT THEY WERE CAUSING HER DISCOMFORT. SHE ALSO REPORTED THAT THERE WAS A BEND ON THE END OF HER SENSORS. SHE ALSO REPORTED HAVING IRRITATION WITH ALL THE TAPE USED FOR HER INFUSION SETS AND SENSOR. CUSTOMER ALSO STATED SHE WAS HAVING ADHESIVE ISSUES WITH HER SENSORS. THE CUSTOMER'S BLOOD GLUCOSE WAS 197 MG/DL. THE CUSTOMER WAS ADVISED TO SEEK SUGGESTIONS FROM HER HEALTHCARE PROVIDER. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654763 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A K203U

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR