BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5121037 · Received October 1, 2015

    Report

    Report Number
    2032227-2015-52147
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD SENSOR ANOMALY. CUSTOMER'S BLOOD GLUCOSE WAS 222 MG/DL. THE CUSTOMER STATED THAT THE NEEDLE BROKE OFF WHEN PUT IN THE SERTER. THE CUSTOMER REPORTED THAT THE HUB ASSEMBLY ISN'T INSIDE SERTER. CUSTOMER DID NOT IN HER ARM WHEN PRESSURE THE BUTTON. THE CUSTOMER HANG UP THE PHONE DURING THE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647305 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR