BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 8419514 · Received March 14, 2019

    Report

    Report Number
    2032227-2019-02275
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    January 27, 2019
    Report Date
    March 14, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    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

    IT WAS REPORTED THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 14 MMOL/L AND THE SENSOR GLUCOSE WAS 3.2 MMO/L. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. CUSTOMER STATES THE SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 3.2 MMO/L. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 3.5 MMO/L. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANG. CUSTOMER STATES LAST SENSOR DID HAVE SOME BLOOD ON REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216041 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1