BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1811042 · Received August 10, 2010

    Report

    Report Number
    3004209178-2010-82424
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE CUSTOMER JUMPED INTO THE POOL WHILE WEARING THE DEVICE. THE MOTHER ALSO STATED THAT WATER UNDER THE DISPLAY WAS OBSERVED, AND THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. NO FURTHER INFO 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 14 YR