BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4190537 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41075
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HOSPITALIZED. AT THE TIME OF REPORTING, HER BLOOD GLUCOSE WAS 180MG/DL. THE CUSTOMER REPORTED THAT SHE HAD LOST A SENSOR AND, WHEN SHE TRIED TO PUT ANOTHER ONE IN, IT FELL APART. THE NEXT SENOR SHE INSTALLED BEGAN TO MALFUNCTION IN THE FORM OF REPEATED FALSE LOW PREDICT WARNINGS. SHE WAS INFORMED THE FAULTY SENSOR WOULD BE RETURNED AND REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667786 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization