BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 7816970 · Received August 27, 2018

    Report

    Report Number
    2032227-2018-18377
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 30, 2018
    Report Date
    August 26, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF OVER 22.2 MMOL/L. THE CUSTOMER TREATED THROUGH INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 22.2 MMOL/L AND THE SENSOR GLUCOSE READING WAS 23 MMOL/L. THE SENSOR WAS NOT RETURNED FOR ANALYSIS. FRN-RESERVOIR OZO- SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660958 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1