BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1912932 · Received November 18, 2010

    Report

    Report Number
    2032227-2010-83208
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN SCREEN AND CONSTANT TONE DUE TO A PROBLEM WITH THE MOTHER BOARD. UNABLE TO TEST THE BUTTON KEYPAD DUE TO THE FROZEN SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR