BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 2344260 · Received November 15, 2011

    Report

    Report Number
    MW5023154
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Date of Event
    April 5, 2011
    Report Date
    November 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PARADIGM INSULIN PUMP WENT OFF WARRANTY (B)(6) 2011. INFO REC'D INDICATES THE SCREEN ON THE PUMP IS SCRATCHED AND THE BUTTONS OCCASIONALLY STICK AND DO NOT ALWAYS RESPOND TO INITIAL COMMANDS. THE SERIAL NUMBER OF THE PUMP WAS REQUESTED, HOWEVER, IT HAS NOT BEEN SUBMITTED TO US. DATE OF USE: (B)(6) 2007 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM 722 LZG MEDTRONIC MINIMED PARADIGM 722

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR