BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984415 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-89979
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS STATES THAT INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR. ALARM WAS DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO FROZEN DISPLAY NOTED. PUMP WAS RECEIVED WITH A SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460768 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR