BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4150327 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35136
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SENSORS MALFUNCTIONED. THE FIRST SENSOR HAD A BENT CANNULA, THE SECOND SENSOR HAD AN ELECTRODE OR NEEDLE THAT FRACTURED WHILE IT WAS IN THE USER'S BODY, AND THE THIRD HAD AN ELECTRODE THAT COULD NOT BE FOUND. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING. THE SENSOR NEEDLE WAS NOT REPORTED TO BE DIFFICULT TO REMOVE, AND THE NEEDLE BREAK WAS NOTED UPON REMOVAL OF THE SENSOR. THE CUSTOMER STATED THAT THERE WAS AN UPCOMING APPOINTMENT FOR OPERATION AT THE HOSPITAL UNRELATED TO DIABETES, ADVISING THAT THE ISSUE WOULD BE DISCUSSED WITH THE DOCTOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629809 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention