BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020C1 GS3 5PK 9L OUS1

    MDR report key: 12329699 · Received August 17, 2021

    Report

    Report Number
    2032227-2021-181195
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 25, 2021
    Report Date
    August 16, 2021
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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

    INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE 14 MMO/L AND SENSOR GLUCOSE WAS 3.4 MMO/L AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 3.9 MMO/L. THE SENSOR HAD CHANGE SENSOR, CALIBRATION NOT ACCEPTED AND SENSOR UPDATING, CANNOT FIND SENSOR SIGNAL ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231773 SENSOR MMT-7020C1 GS3 5PK 9L OUS1 ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020C1

    Patients

    Seq Age Sex Outcome Treatment
    1