BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 1810984 · Received August 9, 2010

    Report

    Report Number
    3004209178-2010-82405
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND MOTOR ASSEMBLY. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS PUSHED IN THE POOL WHILE WEARING THE INSULIN PUMP. THE CUSTOMER STATED THAT THE BUTTONS WERE UNRESPONSIVE, WATER UNDER THE DISPLAY CAN BE OBSERVED, AND THE DEVICE ALARMED AT TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1