BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 8702710 · Received June 17, 2019

    Report

    Report Number
    2032227-2019-16742
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 16, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THERE WAS NO ELECTRODE PART OF THE SENSOR WHEN THE SENSOR WAS REMOVED. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496243 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1