BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4231772 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-36114
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    January 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT LAST WINTER SHE WAS OUT OF THE STATE AND HAD ISSUES INSERTING HER SENSOR. SHE COULD NOT SEPARATE THE SENSOR AND THE SERTER. CUSTOMER RECEIVED A NEW SERTER SINCE THEN IT SEEMS TO BE WORKING FINE NOW. CUSTOMER ALSO MENTIONED THAT SHE HAD ISSUES WITH BENT CANNULAS ON HER INFUSION SETS. THERE WAS AN INSTANCE WHERE HER BLOOD GLUCOSE WAS HIGH DUE TO A BENT CANNULA. CUSTOMER'S BLOOD GLUCOSE WAS 423 MG/DL. SHE HAD TO CHANGE HER INFUSION SET AND RESERVOIR. REPLACEMENT SUPPLIES WERE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715668 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A J013U

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention