BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223362 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46830
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNABLE TO PERFORM OPERATING CURRENTS, SELF TEST, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO BLANK DISPLAY. UNIT RECEIVED WITH BLANK DISPLAY DUE TO BROKEN SOLDER JOINT B1 I/B. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED CRACKED CASE DISPLAY WINDOW CORNER. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH BROKEN RESERVOIR TUBE LIP. (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 NEEDS A COMPLETE FUNCTIONAL ANALYSIS. THE BLOOD GLUCOSE LEVEL WAS NOT INCLUDED IN THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707447 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1