BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 7747898 · Received August 3, 2018

    Report

    Report Number
    3004209178-2018-99281
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    July 6, 2018
    Report Date
    August 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    20763000118864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 118, 180 MG/DL AND SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 39 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. THE CUSTOMER REPORTED THAT THERE WAS BLOOD AT THE SITE AFTER INSERTION OF SENSOR. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CHANGE SENSOR AND CALIBRATION NOT ACCEPTED ALARM. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588329 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020A HG2H4TS 20763000118864

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other