BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 530G WITH ENLITE

    MDR report key: 4231691 · Received October 31, 2014

    Report

    Report Number
    MW5038959
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS REGARDING THE MEDTRONIC MINIMED 530G WITH ENLITE SENSORS: I'VE HAD MANY, MANY OCCURRENCES OF THE SENSOR GIVING WILDLY INACCURATE READINGS. THIS HAS LED TO LOSING CONSCIOUSNESS AND HAVING MANY OCCASIONS OF NEEDING MEDICAL ASSISTANCE FROM MY WIFE AND CHILDREN. I AM HYPOGLYCEMIA UNAWARE SO I HAVE NO PHYSICAL SIGNS WHEN IT DROPS TO DANGEROUS LEVELS. THIS DEVICE HAS HELPED MANY TIMES BUT FAILED TOO MANY TIMES TO COUNT. I'VE DISCUSSED THIS SO MANY TIMES WITH THEIR VERY HELPFUL CUSTOMER SUPPORT PERSONNEL. HOWEVER, THEY HAVE BEEN UNABLE TO FIGURE OUT THE CAUSE OR HELPED TO RECTIFY THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698097 MINIMED 530G WITH ENLITE 530G WITH ENLITE OYC MEDTRONIC MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| O| R