BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 8622700 · Received May 20, 2019

    Report

    Report Number
    2032227-2019-04245
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    January 15, 2019
    Report Date
    November 13, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED 1 OPENED/USED SENSOR AND PERFORMED VISUAL INSPECTION AND FOUND CANNULA SEPARATED FROM TUBING. UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED/USED.

    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 246 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN DELIVERY WAS SUSPENDED DUE TO THE SENSOR VALUES. THE CUSTOMER STATED THAT THE SENSOR VALUE THAT TRIGGERED THE SUSPEND ON LOW OR SUSPEND BEFORE LOW EVENT WAS BELOW 46 MG/DL. THE SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 45 MG/DL. THE BLOOD GLUCOSE VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT WAS 246 MG/DL. THE CUSTOMER REPORTED THAT THE DIFFERENCE OCCURS WITH THE PREVIOUS SENSOR. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416635 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR