BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974322 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89070
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    March 14, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS ALSO RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE LIP AND SCRATCHED DISPLAY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE. THE REPORTER HAD TAKEN THE BATTERIES OUT DURING THE NIGHT AND INSERTED NEW BATTERIES IN THE MORNING. THE BLOOD GLUCOSE READING AT THE TIME WAS 24.3 MMOL/L. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449870 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