BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3081651 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92809
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD HIGH BLOOD SUGARS AND STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDING ON HIS INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP IS ALARMING AND UNABLE TO EXIT THE PREPARING TO PRIME LOOP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185074 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR