BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6189733 · Received December 20, 2016

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    Report

    Report Number
    2032227-2016-51521
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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 REPORTED VIA PHONE CALL THAT THEY RECEIVED 3 SENSORS THAT WERE MISSING THE ELECTRODE AND DID NOT WORK. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO FURTHER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840700 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A I146P

    Patients

    Seq Age Sex Outcome Treatment
    1