BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4140834 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33194
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO FLATTENED ACT BUTTON DOME SWITCH, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, MISSING END CAP STICKER. UNABLE TO PERFORMED THE DISPLACEMENT TEST DUE TO KEYPAD ANOMALY. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 INSULIN PUMP WAS RETURNED WITHOUT AUTHORIZATION AND WITHOUT ANY COMMUNICATION REGARDING THE REASON FOR THE RETURN. WHEN THE INSULIN PUMP WAS GIVEN TO THE REPRESENTATIVE IT WAS STATED THAT THE INSULIN PUMP HAD ALARMED BUTTON ERROR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619643 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1