BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3240688 · Received July 22, 2013

    Report

    Report Number
    2032227-2013-03073
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED AND HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 21 MG/DL WHEN PARAMEDICS ARRIVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340100 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization