BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 8538420 · Received April 22, 2019

    Report

    Report Number
    3004209178-2019-85736
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    April 14, 2019
    Report Date
    February 10, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    20763000140940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED OR USED SENSOR AND PERFORMED CONTINUITY RESISTANCE TEST AND SENSOR FAILED TEST. FOUND CANNULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED OR USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 143, 158 MG/DL AND THE SENSOR GLUCOSE VALUE FROM REPORTED EVENT WAS 65 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. CUSTOMER HAD RECEIVED A CALIBRATION NOT ACCEPTED AND CHANGE SENSOR ALERT. THE SENSOR WILL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331101 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020A HG2YTT5 20763000140940

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR