BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2101517 · Received May 20, 2011

    Report

    Report Number
    2032227-2011-01282
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 17, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 900 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE FOR TWO DAYS. THE CUSTOMER CHANGED THE INFUSION SET FOUR TIMES, BUT HER BLOOD GLUCOSE REMAINED ELEVATED. THE CUSTOMER WAS ALSO VOMITING. THE CUSTOMER HAS NOT HAD ANY ISSUES SINCE BEING RELEASED FROM THE HOSPITAL. 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-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization