BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972077 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05077
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 21, 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
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNIT RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, MISSING END CAP STICKER, AND MISSING ADDRESS/SERIAL NUMBER LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR AND IS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 132 MG/DL. CUSTOMER'S MOTHER STATED, THE CUSTOMER WAS AT SCHOOL AND THE NURSE CALLED HER TO INFORM HER THE CUSTOMER'S DEVICE WAS ALARMING. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447156 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR