BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933441 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03877
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. 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

    CUSTOMER REPORTED THAT HIS SENSOR BECAME STUCK INSIDE OF THE SERTER. HE STATED THAT HE USED A PEN TO GET IT OUT BUT THE NEEDLE WAS BENT. CUSTOMER STATED THAT HIS CURRENT SENSOR WAS IN HIS ABDOMEN BUT APPEARED TO BE COMING LOOSE. HE WAS ADVISED TO LET THE SENSOR SIT FOR AN HOUR IN HIS BODY BEFORE ATTEMPTING TO START A NEW SENSOR IN THE INSULIN PUMP. CUSTOMER WAS ADVISED TO AVOID INSERTING IN AREAS THAT GO THROUGH A LOT OF MOTION. CUSTOMER STATED THAT HE PERSPIRES DUE TO WHERE HE LIVES AND THAT HE IS VERY ACTIVE. THE BLOOD GLUCOSE READING WAS 130 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411142 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR