BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142560 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01500
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DELIVERED A BOLUS THAT HE DID NOT PROGRAM. THE CUSTOMER UPLOADED THE INSULIN PUMP TO CARELINK, AND FOUND A BOLUS OF 1.8 UNITS WAS DELIVERED IN THE MORNING. THE CUSTOMER STATED THAT THIS WAS NOT THE FIRST TIME IT HAD HAPPENED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP IS EITHER PROGRAMMING THE BOLUS ON ITS OWN OR SOMEHOW HE IS PRESSING THE BUTTONS. THE CUSTOMER STATED THAT HE WOULD MONITOR THE INSULIN PUMP, AND CALL BACK IF NEEDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR