BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2033943 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80726
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUTTON ERROR ALARM AND INTERMITTENT BUTTON RESPONSE WAS DUE TO MOISTURE DAMAGE ON THE BUTTON KEYPAD TRACE. NO BLANK DISPLAY OR ALARM ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM. THE CUSTOMER STATED THAT ONE DAY PRIOR TO THE EVENT, THE INSULIN PUMP WAS NOT WORKING AFTER GIVING A LONG BUTTON ERROR ALARM. THE CUSTOMER FURTHER STATED THAT THE BUTTONS WERE UNRESPONSIVE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization