BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130834 · Received May 24, 2013

    Report

    Report Number
    2032227-2013-02168
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED, ALL UNITS MATCHED IN STATUS SCREEN. UNIT COMMUNICATED PROPERLY WITH THE METER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED LOW BLOOD GLUCOSE OF 38 MG/DL. CALLER STATED THAT THE INSULIN PUMP OVER INSULIN BY DELIVERING 50.0 UNITS OF INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232833 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR