BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1830086 · Received September 7, 2010

    Report

    Report Number
    3004209178-2010-82711
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AS A RESULT OF CORROSION ON THE LIQUID CRYSTAL DISPLAY BOARD AND THE KEYPAD TRACE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT FUNCTIONING AFTER THE DEVICE WAS DROPPED IN THE TOILET. THE CUSTOMER STATED THAT SHE DRIED THE DEVICE, BUT THE BUTTONS WERE NOT RESPONDING. 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 36 YR