BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1981867 · Received February 2, 2011

    Report

    Report Number
    2032227-2011-00317
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 1531 MG/DL. THE CUSTOMER WAS IN A COMA AT THE TIME OF ADMISSION. THE CUSTOMER STATED THAT THE EVENT WAS DUE TO BENT CANNULAS, AND DIDN'T FEEL THE NEED TO TROUBLESHOOT THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization