BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972068 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05070
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 25, 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
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOANER INSULIN PUMP RETURNED AND IT WAS RECEIVED WITH SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER ORIGINALLY COMPLAINED ABOUT RECEIVING A MOTOR ERROR ALARM ON THE INSULIN PUMP DURING PRIME. CUSTOMER STATED HE DOES NOT RECALL ANY EVENTS LEADING TO THE ALARM. CUSTOMER DOES USE THE SENSOR FEATURE AND HE IS ABLE TO REWIND THE INSULIN PUMP. IT WAS ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY AT THE REWIND PROCESS. BLOOD GLUCOSE LEVEL 153 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447153 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR