BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 8726080 · Received June 24, 2019

    Report

    Report Number
    2032227-2019-20287
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 15, 2019
    Report Date
    June 24, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 105 MG/DL AND SENSOR GLUCOSE VALUE THAT TRIGGERED SUSPEND EVENT WAS 40 MG/DL. THE DIFFERENCE BETWEEN THE SENSOR GLUCOSE LEVEL AND BLOOD GLUCOSE LEVEL WAS 65 MG/DL THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519730 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR