BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2133672 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01392
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INITIALLY CALLED TO REPORT LOW BATTERY LIFE. THE CUSTOMER THEN REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS AND A SEIZURE. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER'S PRIMING TECHNIQUE IS CORRECT. THE PROGRAMMING WAS NOT REVIEWED AS THE CUSTOMER'S BASAL RATES HAD JUST BEEN CHANGED. THE RESERVOIR VOLUME WAS ACCURATE. 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-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization