BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3122967 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-02015
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    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 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 INSULIN PUMP GAVE A MOTOR ERROR ALARM, AND THE DRIVE SUPPORT CAP WAS PROTRUDING. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. HOWEVER, THE MOTOR ERROR OCCURRED MORE THAN ONCE IN 30 DAYS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225117 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAP

    Patients

    Seq Age Sex Outcome Treatment
    1