BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4182681 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39669
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED FUNCTIONAL TESTING WITH ISIG VALUE 26.94NA, VCTR -1.08V, BATTERY VOLTAGE 3.89V, FREQUENCY 916.55MHZ, AMPLITUDE -19.46DB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS IN THE RANGE OF 130 MG/DL AND 140 MG/DL. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER ALSO REPORTED THAT THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP ACTIVATED EVEN THOUGH IT WAS NOT SUPPOSED TO. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ACTIVATED THE THRESHOLD SUSPEND WHICH WAS SET AT 50 MG/DL AND IT ACTIVATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661281 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR