BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4791168 · Received May 22, 2015

    Report

    Report Number
    2032227-2015-16535
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND NO ANOMALY COULD BE CONFIRMED DUE TO THE SENSOR BEING SENT OPENED AND USED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR EXPERIENCED AN ANOMALY. THE CUSTOMER STATED THAT WHEN HE REMOVED THE SENSOR FROM HIS BODY, THE ELECTRODE SEEMED TO BE MISSING. HE STATED THAT THERE WAS ONLY A LITTLE STUB OF A SENSOR. HE ALSO REPORTED THAT THE TRANSMITTER DID NOT FLASH WHEN HE CONNECTED THE SENSOR. THE CUSTOMER DID NOT KNOW THE BLOOD GLUCOSE READING. THE CUSTOMER WAS ADVISED TO REPLACE THE SENSOR AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336077 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0G2NY

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR