BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090098 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01167
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT BEING HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER COULD NOT RECALL HER BLOOD GLUCOSE READING AT THE TIME OF ADMISSION. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARMS WHILE ATTEMPTING TO BOLUS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER WAS UNABLE TO CHECK THE INSULIN PUMP SETTINGS AT THE TIME OF THE CALL. 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-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM| INSULIN INFUSION SET MMT-399