BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3972392 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05145
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 REPORTED THAT THE SENSOR WAS INACCURATE AND THE INSULIN PUMP WENT INTO AN INAPPROPRIATE THRESHOLD SUSPEND. SHE STATED THAT WHEN SHE BUMPED INTO THE DOOR FRAME, THE TRANSMITTER WAS RIPPED OUT OF HER BODY AND THAT SOMETIMES WHEN SHE HITS SOMETHING, SHE BLEEDS EXCESSIVELY. THE BLOOD GLUCOSE READING WAS 117 MG/DL. IT WAS FOUND THE CUSTOMER DOES NOT FOLLOW PROPER PROCEDURE AND TAPES THE SENSOR DOWN VERY TIGHTLY AGAINST THE BODY. CUSTOMER REPORTED THAT THIS IS THE FOURTH TIME SHE HAS EXPERIENCED BLOOD AT THE SITE AND THAT TIME, IT WAS GUSHING. CUSTOMER STATED THAT THE SENSOR WAS NOT TUGGED OR PULLED ON AFTER INSERTION AND THAT IT WAS NOT INSERTED AWAY FROM RESTRICTIVE CLOTHING. SHE ALSO STATED THAT THE INSERTION SITES WERE PAINFUL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446756 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A H9212336

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR