BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2060748 · Received April 8, 2011

    Report

    Report Number
    2032227-2011-00892
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OF FOUR UNITS AT 4:15 AM. THE CUSTOMER STATED THAT HE DID NOT PROGRAM THIS BOLUS TO BE DELIVERED. THE CUSTOMER ONLY WANTED THIS DOCUMENTED, AND DID NOT REQUEST A REPLACEMENT INSULIN PUMP. THE CUSTOMER STATED THAT IT'S POSSIBLE THAT THE BUTTONS MAY HAVE ACCIDENTALLY BEEN PRESSED DURING THE NIGHT. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP CLOSELY AND CALL BACK AS 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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR