BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6117216 · Received November 21, 2016

    Report

    Report Number
    2032227-2016-36879
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM DUE TO FLATTENED BUTTON DOME SWITCH. UNABLE TO PERFORM DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO BUTTON ERROR ALARM. DEVICE HAD 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769790 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAP

    Patients

    Seq Age Sex Outcome Treatment
    1