BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 10912770 · Received November 26, 2020

    Report

    Report Number
    2032227-2020-210798
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    April 1, 2019
    Report Date
    November 26, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING PAST HOSPITALIZATION GLUCOSE FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON NOVEMBER 16, 2020. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372974 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 38 YR