BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3113709 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-93489
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    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 DUAL/SQUARE BOLUS AND ALL DELIVERED AND RECORDED PROPERLY IN BOLUS HISTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD EXPERIENCED SEVERAL LOW BLOOD GLUCOSE DUE TO HER INSULIN PUMP OVER DELIVERED. CUSTOMER STATED THAT HER INSULIN PUMP SQUARE BOLUS IS NOT WORKING CORRECTLY IT DELIVERED MORE INSULIN AND IS NOT RECORDING IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214028 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR