BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2001662 · Received February 18, 2011

    Report

    Report Number
    2032227-2011-00496
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 433 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET THE DAY PRIOR TO BEING ADMITTED. THE CUSTOMER HAD NOT ATTEMPTED ANOTHER INFUSION SET CHANGE OR MANUAL INJECTION TO TRY TO SOLVE THE ISSUE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE INSULIN PUMP WAS PROGRAMMED, BUT THE CUSTOMER DID NOT KNOW IF THE PROGRAMMING WAS CORRECT. ADVISED TO HAVE THE CUSTOMER SPEAK WITH HER DOCTOR TO VERIFY THE PROGRAMMING. 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-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization