BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3790164 · Received May 5, 2014

    Report

    Report Number
    2032227-2014-02246
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2014-84141.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT HER INSULIN PUMP WAS CONSTANTLY ALARMING SENSOR ERROR. CUSTOMER STATED THAT THE SENSOR WAS GIVING INCORRECT READINGS, SHE TOOK IT OFF AND NOTICED THAT THE CANNULA WAS BENT AND WITH BLOOD IN IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266712 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization