BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2133776 · Received May 12, 2011

    Report

    Report Number
    2032227-2011-01194
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 9, 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 FROZEN SCREEN WHEN THE BATTERY WAS INSTALLED DUE TO A PROBLEM WITH THE MOTHER BOARD. UNABLE TO VERIFY THE ALARMS DUE TO THE FROZEN SCREEN. NO BLANK DISPLAY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ALARM THAT SHE COULD NOT CLEAR DUE TO A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. AFTER CHANGING THE BATTERY, THE SCREEN WENT BLANK. TROUBLESHOOTING WAS PERFORMED, BUT THE SCREEN DID NOT RETURN. 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-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR