BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4251585 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52796
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A21 AFTER BATTERY CHANGE AND MEMORY RESET AFTER BATTERY CHANGE DUE TO FAULTY C13 ON IB. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED DISPLAY WINDOW CORNER.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN UNEXPECTED RESTART ALARM AFTER REPLACING THE BATTERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 270 MG/DL. THE PRODUCT WAS RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736245 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCML

    Patients

    Seq Age Sex Outcome Treatment
    1