BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945525 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04557
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 THAT THE CUSTOMER WEAK SIGNAL AND CHANGE SENSOR ALERTS. CUSTOMER STATED THE SENSOR STOPPED FUNCTIONING ON THE FOURTH DAY OF INSERTION. TROUBLESHOOT NOT PERFORMED AS THE CUSTOMER STATED THAT THE INSULIN PUMP AND SENSOR WERE NOT AVAILABLE AT THE TIME. CUSTOMER STATED THAT HAS HAD OTHER SENSORS MALFUNCTION AND ISSUE HAS ONLY BEEN ON SENSORS FROM THE SAME BOX. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425004 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR