BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4223068 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46842
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS NOT REQUIRED. UNABLE TO PERFORM INSERTION TEST DUE TO SENSOR RETURNED OPENED OR USED. INSERTION NEEDLE NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE OF 34 MG/DL; TREATED WITH JUICE. CUSTOMER STATED THAT ONE SENSOR BROKE IN THE SERTER. CUSTOMER ALSO REPORTED THAT SHE HAD BLEEDING AT INSERTIONS SITE TWICE. CUSTOMER STATED THAT THE SITE IS NOT ACTIVELY BLEEDING AND BLOOD IS VISIBLE ON THE SENSOR CONNECTOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706171 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B214U

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR