BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4213429 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-36920
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 24, 2014
    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 MOISTURE DAMAGE ON THE ELECTRONICS AND MOTOR. UNIT HAD CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW AND MISSING END CAP STICKER. 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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD MOISTURE DAMAGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647437 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAL

    Patients

    Seq Age Sex Outcome Treatment
    1