BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4182705 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39895
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 REPORTS THAT THE NEWLY INSERTED SENSOR WAS FELT AT THE BACK OF THE KNEE. CUSTOMER INSERTED SENSOR ON HER LOVE HANDLES INSTEAD OF IN THE ABDOMEN. CUSTOMER WAS ADVISED THAT SINCE SENSOR WAS BEING WORN OFF LABLE THAT IT COULD NOT BE REPLACED. CUSTOMER STATES SHE WAS ADVISED BY TRAINER NOT TO INSERT IN THE ABDOMEN, BUT TO INSERT IN THE LOVE HANDLES. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660102 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR