BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2142398 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01530
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 710 MG/DL. THE CUSTOMER STATED THAT SHE WAS VOMITING PRIOR TO BEING ADMITTED. THE CUSTOMER HAD CHANGED THE INFUSION SET ON THE MORNING OF THE HOSPITALIZATION, AND HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS ALL MORNING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER COULDN'T CONDUCT THE HIGH PRESSURE TEST 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-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization