BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972486 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05233
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. CRACKED CASE AT DISPLAY WINDOW CORNER AND SEVERELY SCRATCHED LCD WINDOW NOTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOMER RECIEVED BOTTON ERROR ALARM. CUSTOMERS BLOOD GLUCOSE LEVEL IS 246MG/DL. INSULIN PUMP IS BEING REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449960 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR