BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972001 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88614
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED ON THE INSULIN PUMP. THERE WAS INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE TO THE KEYPAD TRACE. THE DEVICE WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND BATTERY OUT LIMIT. THE CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. THE CUSTOMER STATED THAT THEY ALWAYS KEEP THE INSULIN PUMP IN THEIR BRA, AND NEVER HAD AN ISSUE WITH IT. NOTHING HAPPENED PRIOR TO THE BUTTON ERROR ALARM. THE CUSTOMER WAS ADVISED TO PLACE THE INSULIN PUMP IN A BABY SOCK IN ORDER TO AVOID MOISTURE EXPOSURE WHILE THE DEVICE IS BEING KEPT IN THE BRA. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447081 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR