BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC 530G W/ ENLITE SENSOR

    MDR report key: 4352878 · Received December 19, 2014

    Report

    Report Number
    MW5039699
    Event Type
    Other
    Date Received
    December 19, 2014
    Date of Event
    December 19, 2014
    Report Date
    December 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THAT HE IS A TYPE 1 BRITTLE DIABETIC. HE RECEIVED AN INACCURATE READING FROM HIS MEDTRONIC 530G WITH ENLITE SENSOR. THE SENSOR READ 202MG/DL AND HIS ONE TOUCH METER READ 290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835867 MEDTRONIC 530G W/ ENLITE SENSOR MEDTRONIC 530G W/ ENLITE SENSOR OZO MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR