BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4991097 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-26596
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT RESPONSE FROM ESC BUTTON, DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS ALSO RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, CRACKED LCD WINDOW, AND A SCRATCHED RESERVOIR TUBE WINDOW. 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

    THE CUSTOMER CALLED AND REPORTED THAT NONE OF THE BUTTONS ON THE INSULIN PUMP WERE WORKING. CUSTOMER'S BLOOD GLUCOSE WAS 232 MG/DL. 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
    525338 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1