BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4141796 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33559
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-17187.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND PARAMEDICS WERE CALLED. CUSTOMER STATED SHE PASSED OUT, HER HUSBAND GAVE HER CANDY AND BY THE TIME PARAMEDICS ARRIVED, CUSTOMER'S BLOOD GLUCOSE STARTED TO RISE AND DID NOT NEED PARAMEDIC ASSISTANCE. CUSTOMER REPORTED THE SENSOR WAS READING HER GLUCOSE IN THE 100 MG/DL RANGE. CUSTOMER'S BLOOD GLUCOSE WAS 27 MG/DL. CUSTOMER REPORTED THAT SHE STARTED VOMITING AND MIGHT HAVE EATEN GLUTEN WHICH SHE IS ALLERGIC TOO. CUSTOMER DECLINED TROUBLESHOOTING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621437 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention