BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL -TIME INSULIN INFUSION PUMP

    MDR report key: 4160171 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25334
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEN 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 HAD HIGH BLOOD GLUCOSE LEVELS OF 396 MG/DL. THE CUSTOMER TREATED WITH MANUAL INSULIN SHOTS. THE CUSTOMER REPORTED A COMPROMISED FORCE SENSOR SYSTEM ERROR FROM THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581483 PARADIGM REAL -TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1