BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 8762040 · Received July 4, 2019

    Report

    Report Number
    2032227-2019-24930
    Event Type
    Malfunction
    Date Received
    July 4, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 4, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    UDI-DI
    20643169541706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 SENSOR ELECTRODE AND INSERTION NEEDLE WAS MISSING, THEY PLACED THE SENSOR INTO THE INSERTER AND CHECKED THE SENSOR AND THEY DID NOT SEE ANYTHING ON THE BOTTOM OF THE SENSOR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE DEVICE WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555885 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008A D039P 20643169541706

    Patients

    Seq Age Sex Outcome Treatment
    1