BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008B

    MDR report key: 8905170 · Received August 19, 2019

    Report

    Report Number
    2032227-2019-48575
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 10, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169786738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR GLUCOSE VALUE THAT TRIGGERED SUSPEND ON LOW OR SUSPEND BEFORE LOW EVENT WAS 60 MG/DL. LOW LIMIT IN SENSOR SETTINGS WAS 70. THE BLOOD GLUCOSE VALUE ASSOCIATED WITH THE TRIGGERED SUSPEND EVENT 169 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
    700562 SENSOR ENLITE MMT-7008B ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7008B HG3EKTNH11 00643169786738

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR