BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3093749 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01684
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    IT IS REPORTED THAT CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING AT TIME OF HOSPITALIZATION WAS 1.2 MMOL/L. CUSTOMER STATED THAT HE HAD LITTLE SLEEP IN THIRTY-SIX HOURS AND HAD A LOT OF ACTIVITIES TO ATTEND. MANUAL PRIME IS CORRECT. PROGRAMMING IS CORRECT. DISPLACEMENT TEST PASSED. CUSTOMER'S INSULIN PUMP WAS EXPOSED TO BODY SCANNER AT AIRPORT. ADVISED CUSTOMER THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196776 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization