BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4801243 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59883
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    June 11, 2014
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT RESPONSE OF A BUTTON, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM OCCURRED DURING TESTING.THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW, AND A CRACKED BELT CLIP SLOT.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

    THE CUSTOMER'S PARENT CALLED AND REPORTED THE INSULIN PUMP ALARMED WITH BUTTON ERROR AND THE BUTTONS STOPPED RESPONDING. CUSTOMER'S BLOOD GLUCOSE WAS 14.2 MMOL/L. CUSTOMER WAS ADVISED THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347393 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CMP

    Patients

    Seq Age Sex Outcome Treatment
    1