BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3103555 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-93308
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY AND E70 ALARM CONFIRMED IN THE HISTORY FILE. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUT TESTING. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY ALARM TESTS DUE TO MOTOR ERROR ALARM. HOWEVER, UNIT PASSED THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS OVER 590 MG/DL. CUSTOMER STATED THAT HIS INSULIN PUMP BROKE AND HE SPENT 11 HOURS WITHOUT INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203094 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization