BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110227 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-93394
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    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. HOWEVER, UNIT DID NOT COMMUNICATED PROPERLY WITH TEST DUE TO FAULTY COMPONENT ON THE DISPLAY BOARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE AND DKA. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM WAS OVER 600 MG/DL. CUSTOMER STATED THAT HE HAD NO DELIVERY ALARMS PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210504 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization