BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3002212 · Received March 13, 2013

    Report

    Report Number
    2032227-2013-00980
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 SHE HAS LOW BLOOD GLUCOSE DUE TO HER INSULIN PUMP IS OVER DELIVERING. CUSTOMER STATED THAT SHE NOTICED INSULIN DELIVERED AFTER THE INSULIN PUMP WAS SUSPENDED. CUSTOMER STATED THAT SHE DID A MANUAL PRIME AND THE INSULIN CONTINUES TO DRIP AFTER THE MOTOR STOPS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105085 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR