BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4230872 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48402
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A SENSOR GLUCOSE AND BLOOD GLUCOSE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER WAS TREATED. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED NOT TO CALIBRATE ON SENSOR ALERT. THE CUSTOMER WAS ADVISED NOT TO DELAY ENTRY ON BLOOD GLUCOSE READING INTO INSULIN PUMP AFTER TESTING BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED THAT WE WILL SHIP A REPLACEMENT FOR SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713591 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG05Z0J

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening