BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3864653 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03041
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2014-03040.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA E-MAIL THAT THE CUSTOMER WAS HOSPITALIZED IN INTENSIVE CARE UNIT DUE TO LOW BLOOD GLUCOSE. CALLER STATED THAT THE CUSTOMER BOLUSED FOR CORRECTION, HER BLOOD GLUCOSE DROPPED AND HAD A SEIZURE. CALLER ALSO STATED THAT THE CUSTOMER WAS USING INCORRECT SENSORS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338939 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization