BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PU,P

    MDR report key: 4250355 · Received November 7, 2014

    Report

    Report Number
    2032227-2014-49535
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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 PATIENT REPORTED THAT THE INSULIN PUMP IS NOT STORING INFORMATION, LOADED JAVA AND IS STILL NOT GETTING READINGS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER GOT DISCONNECTED BEFORE BEING TRANSFERRED OVER AND ATTEMPTED TO CALL BACK BUT NO ANSWERED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719480 INSULIN INFUSION PU,P OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR