BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1810981 · Received August 9, 2010

    Report

    Report Number
    3004209178-2010-82403
    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
    SC, 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 CORROSION ON THE RADIO FREQUENCY BOARD, INTERFACE BOARD, AND MOTOR HOME SWITCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER JUMPED IN THE WATER WHILE WEARING THE INSULIN PUMP AND THE DEVICE HAD A BLANK DISPLAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR