BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 4191278 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41556
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS RECEIVING MULTIPLE NO DELIVERY ALARMS FROM HIS INSULIN PUMP. AT THE TIME OF REPORTING THE CUSTOMER'S BLOOD GLUCOSE WAS 215 MG/DL. THE CUSTOMER PERFORMED A FIVE UNIT FIXED PRIME TO DETERMINE IF THE CANNULA OR THE SIGHT CONNECTION WERE OCCLUDED. THE CUSTOMER STATED THAT INSULIN WAS COMING THROUGH THE TUBE FOLLOWING THE PRIME. THE CUSTOMER STATED THAT HE CHANGES HIS INFUSION SET EVERY FOUR OR FIVE DAYS. HE WAS ADVISED TO CHANGE IT EVERY TWO TO THREE DAYS IN THE FUTURE. NO EQUIPMENT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669164 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR