BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1981858 · Received February 2, 2011

    Report

    Report Number
    2032227-2011-00331
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    July 1, 2010
    Report Date
    January 23, 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 REPORTED BEING HOSPITALIZED SIX MONTHS AGO FOR BLOOD GLUCOSE LEVELS OVER 300 MG/DL. THE CUSTOMER WAS TAKEN OFF OF INSULIN PUMP THERAPY AFTER THE EVENT, AND WAS NOW WONDERING IF HE SHOULD GET BACK ON THE INSULIN PUMP. ADVISED THAT WE CANNOT ASSIST WITH THAT. ADVISED TO APEAK WITH HIS DOCTOR. 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-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization