BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1810997 · Received August 9, 2010

    Report

    Report Number
    3004209178-2010-82396
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AS A RESULT OF MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY. ALSO, MOISTURE DAMAGE WAS FOUND ON THE BATTERY TUBE AND THE MOTOR ASSEMBLY. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS SUBMERGED IN WATER AND MOISTURE UNDER THE DISPLAY WAS OBSERVED. THE CUSTOMER ALSO REPORTED THAT THE BUTTONS WERE NOT RESPONDING. THE BATTERY WAS CHANGED AND THE BUTTONS STILL WERE UNRESPONSIVE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR