BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982041 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89109
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC ASSEMBLY OR MOTOR ASSEMBLY PER VISUAL INSPECTION. THE INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS, SEVERELY SCRATCHED DISPLAY WINDOW, AND A MISSING END CAP STICKER. NO UNEXPECTED VIBRATION ANOMALY NOTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CUSTOMER KEEPS RECEIVING A BUTTON ERROR ON HIS INSULIN PUMP. THE CUSTOMER STATES THAT THE ERROR COULD HAVE BEEN RESULTED WHEN HE HAD PUT THE INSULIN PUMP INSIDE THE POCKET OF HIS WET SHORTS AFTER GOING SWIMMING. THE CUSTOMER'S BLOOD GLUCOSE IS 314 MG/DL. INSULIN PUMP WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457590 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 37 YR