BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942883 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04430
    Event Type
    Malfunction
    Date Received
    July 17, 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
    ID
    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

    CUSTOMER STATED THAT HE IS TAKING BLOOD THINNER MEDICATION DUE TO A HEART STINT HE GOT INSERTED RECENTLY. CUSTOMER REPORTED THAT HE WILL GET A LOT OF BLOOD AT SITE WHEN HE INSERTS THE SENSOR AND MANAGED TO STOP THE BLEEDING BUT RECEIVED A LOST SENSOR ALERT. DURING TROUBLESHOOT; CUSTOMER STATED HE IS NOT ACTIVELY BLEEDING, THE SENSOR WAS NOT PULLED OR TUGGED AFTER INSERTING. CUSTOMER SATED THAT BLOOD IS VISIBLE ON SENSOR CONNECTOR. CUSTOMER WAS ADVISED TO REPLACE SENSOR DUE TO DAMAGE. BLOOD GLUCOSE OF 111 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419656 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG05C06

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR