BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2021288 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00562
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN TREATED BY PARAMEDICS SIX TIMES DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 28 MG/DL AT THE TIME OF THE MOST RECENT EVENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE DISPLACEMENT TEST PASSED. THE CUSTOMER WAS DISCONNECTED DURING PRIMING. THE CUSTOMER LAST CHANGED HIS INFUSION SET TWO DAYS PRIOR TO THE EVENT. 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 45 YR Required Intervention