BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972066 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05067
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 6, 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
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND SHE IS UNABLE TO CLEAR IT. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. BLOOD GLUCOSE LEVEL 155 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447275 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR