BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1882527 · Received October 21, 2010

    Report

    Report Number
    3004209178-2010-83158
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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 FROZEN DISPLAY AND A CONSTANT TONE AS A RESULT OF A FAULTY ELECTRONIC COMPONENT ON THE INTERFACE BOARD. FURTHER TESTING WAS NOT PERFORMED DUE TO THE FROZEN DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DEVICE WAS NOT ABLE TO COMPLETE A REWIND. 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 47 YR