BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2022843 · Received February 16, 2011

    Report

    Report Number
    2032227-2011-00461
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY DUE TO A PROBLEM WITH THE MOTHER BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLACK SCREEN AND UNRESPONSIVE BUTTONS AFTER INSERTING A NEW BATTERY. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR