BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4243954 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-51155
    Event Type
    Malfunction
    Date Received
    November 11, 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
    CA
    Reporter Occupation
    OTHER

    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

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED BEING IN THE HOSPITAL FOR A NON-DIABETIC ISSUE. THE CUSTOMER WAS INSTRUCTING THE NURSE ON HOW TO PROGRAM A BOLUS USING THE INSULIN PUMP. THE CUSTOMER ACCIDENTALLY PROGRAMMED A BOLUS. THE CUSTOMER WAS INSTRUCTED TO DISCONNECT AT THE QUICK RELEASE THE NEXT TIME THEY NEED TO CANCEL AN ACTION BY THE INSULIN PUMP. THE CUSTOMER WAS ADVISED BY THE HEALTH CARE PROFESSIONAL TO AVOID PROGRAMMING BOLUSES SINCE THE CUSTOMER HAS BEEN PLACED ON BLOOD THINNERS. THE CUSTOMER WAS ADVISED TO FOLLOW THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725596 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1