BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4862387 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19879
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD BLOOD GLUCOSE LEVELS IN THE 40MG/DL RANGE. IT WAS ALSO MENTIONED THAT THE CUSTOMER HAD DIFFERENCES BETWEEN THEIR SENSOR GLUCOSE LEVELS AND BLOOD GLUCOSE LEVELS, AND THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND. TROUBLESHOOTING WAS DECLINED. NO SIGNIFICANT EVENT LEADING UP TO THE INCIDENT WAS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405334 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other