BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032350 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80748
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BUTTON ERROR ALARM DUE TO A CORRODED KEYPAD TRACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, HER BLOOD GLUCOSE LEVELS WENT DOWN TO 30 MG/DL AND THAT SHE HAD FALLEN ON THE INSULIN PUMP. THE CUSTOMER ALSO STATED SHE HAD BEEN HAVING BUTTON ERROR ALARMS ON HER INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED BUT THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention