BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945092 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04507
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    CUSTOMER REPORTED THE TRANSMITTER LIGHT DOES NOT BLINK WHEN CONNECTED WITH SENSOR. CUSTOMER WAS ADVISED TO REPLACE THE SENSOR. CUSTOMER STATED THE SENSOR WAS FLATTENED. SENSOR WAS EXPIRED. NIGHT PRIOR CUSTOMER BUMPED AND THE INSULIN PUMP ALARMED LOST SENSOR. HE STATED IT HURT SO HE DECIDED TO TAPE THE SENSOR DOWN. WHEN HE REMOVED IT NOTICED IT WAS DISLODGED AND FLATTENED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 166 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421283 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A J163U

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR