BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3971979 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88624
    Event Type
    Malfunction
    Date Received
    July 31, 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 Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO RAMPING NUMBERS OR SCROLL BAR MOVING ON ITS OWN WAS NOTED DURING TESTING. THE DEVICE WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYPAD AND BUTTONS. THE CUSTOMER STATED THAT THEY WERE TRYING TO INPUT THEIR BLOOD GLUCOSE VALUE INTO THE INSULIN PUMP AND THE NUMBERS KEPT SCROLLING UP. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448408 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR