BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233623 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48787
    Date Received
    November 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714211 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1