BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1873976 · Received October 15, 2010

    Report

    Report Number
    3004209178-2010-83136
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY AS A RESULT OF A FAULTY COMPONENT ON THE INTERFACE BOARD. FURTHER TESTING WAS NOT PERFORMED DUE TO THE FROZEN DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS CHANGED TWICE AND THE INSULIN PUMP HAD AN ERROR ALARM. THE CUSTOMER STATED THAT THE ACTIVATE BUTTON WAS NOT RESPONDING, AND THE INSULIN PUMP WAS ALARMING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAS PRDGM INSULIN SMOKE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR