BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974640 · Received August 3, 2014

    Report

    Report Number
    2032227-2014-05248
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHED DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE INSULIN PUMP HAS A BUTTON ERROR AND IS NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 180 MG/DL AND DOES NOT RECALL ANY EVENT LEADING TO THE MALFUNCTION, BUT STATES HE HAS BEEN HAVING ISSUES FOR A MONTH. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452390 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR