BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142603 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01522
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY DUE TO CORROSION ON THE LIQUID CRYSTAL DISPLAY BOARD. UNABLE TO VERIFY THE FROZEN DISPLAY DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY AND UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED, AND THE ISSUE WAS NOT RESOLVED. THE TIME ON THE SCREEN WAS NOT ADVANCING. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR