BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4862367 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19848
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    THE CUSTOMER CALLED AND REPORTED THE SENSOR GAVE READINGS THAT WERE WAY OFF FROM CUSTOMER'S BLOOD GLUCOSE, TRIGGERING THE INSULIN PUMP TO SUSPEND. CUSTOMER'S BLOOD GLUCOSE WAS 313 MG/DL AND THE SENSOR READING WAS 72 MG/DL. CALIBRATION AND INSERTION TECHNIQUES WERE REVIEWED. THE SENSOR WILL NOT BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405695 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR