BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4140838 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33116
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. PLEASE, SEE MEDWATCH REPORT 2032227-2014-33192.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED OUT AT A STORE AND HIT THEIR HEAD ON A SHELF, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER WAS USING SENSORS AT THE TIME OF THE INCIDENT. THE CUSTOMER HAD CHECKED THEIR BLOOD GLUCOSE THE MORNING OF THE INCIDENT. LATER THAT DAY, THE CUSTOMER'S SENSOR GLUCOSE SHOWED 250 MG/DL, SO THE CUSTOMER DELIVERED A BOLUS, RELYING ON THE SENSOR READING. BUT THE CUSTOMER'S BLOOD GLUCOSE HAD ACTUALLY BEEN LOW, WHICH CAUSE THE CUSTOMER TO PASS OUT. THE CUSTOMER HAD NOT USED THE SENSORS EVER SINCE. THE CUSTOMER COULD NOT RECALL THEIR BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620224 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention