BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120118 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-28733
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE TO THE KEYPAD TRACE. THE DEVICE HAD A MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP, AND CRACKED RESERVOIR TUBE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER STATED THAT IT SEEMED THAT THE INSULIN PUMP WAS FROZEN. THE CUSTOMER'S BLOOD GLUCOSE WAS 100 MG/DL. THE CUSTOMER STATED THAT THEY HAD REVERTED TO A BACKUP PLAN. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. LATER, THE CUSTOMER CALLED BACK AND STATED THAT THEIR BLOOD GLUCOSE WAS RISING BECAUSE THEY WERE ON MANUAL INJECTIONS AND THEY WANTED TO USE THE INSULIN PUMP EVERY TWO HOURS IN ORDER TO DELIVER BOLUSES. THE CUSTOMER STATED THAT THE BUTTONS WERE NOW WORKING. THE CUSTOMER WAS ADVISED AGAINST DOING SO. THEY WERE ADVISED THAT IT THE BUTTONS WERE STICKING AND NOT WORKING, THEN, AT NIGHT THIS MIGHT CAUSE ISSUES. THE CUSTOMER STATED THAT THEY WOULD REMAIN ON MANUAL INJECTIONS AND WAIT FOR THE REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598080 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR