BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULOIN PUMP

    MDR report key: 4241494 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50638
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 IS REPORTED THAT A CUSTOMER RECEIVED A NO DELIVERY ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED SHE HAD ISSUES WITH THE QUICK RELEASE AND COULD NOT TAKE THE DEVICE OFF TO SHOWER. THE CUSTOMER TRIED CHANGING THE INFUSION AND RESERVOIR SET WHICH CAUSED THE DEVICE TO LEAK. THE REFUSED TO TALK TO THE HELP LINE FOR ASSISTANCE AND STATED THAT THEY HAVE AN APPOINTMENT A CERTIFIED PUMP TRAINER TO HELP WITH THE ADJUSTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721930 INSULOIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR