BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4132456 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31076
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 HER SENSOR READINGS ARE INACCURATE. SHE STATED HER BLOOD GLUCOSE WOULD BE AROUND 40 MG/DL, BUT THE SENSOR READING WOULD BE AROUND 90 MG/DL. THERE WAS ONE SENSOR WHERE THE BACK TAPE WOULD NOT COME OFF. CUSTOMER DECLINED SPEAKING WITH HELP LINE FOR TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610524 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention