BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3870897 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85592
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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 INSULIN PUMP WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. ALL BOLUSES DELIVERED AND WERE LISTED IN THE BOLUS HISTORY SCREEN. THE INSULIN PUMP CALCULATED THE ADDITIONAL BOLUS DELIVERIES AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. NO DELIVERY ANOMALY, DAILY TOTAL ANOMALY, BASAL ANOMALY, BOLUS ANOMALY OR HISTORY ANOMALY NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, SELF TEST, AND ERROR TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF/NO POWER ALARM FUNCTIONS PROPERLY. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP HAD DRIED INSULIN ON MOTOR SLIDE/RESERVOIR COMPARTMENT, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY OR ON MOTOR HOME SWITCH.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. 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 CUSTOMER WAS PUT ON MANUAL DAILY INJECTIONS AND HIS MOTHER DOES NOT TRUST THE INSULIN PUMP. THE CALLER STATED THAT THE DEVICE WAS NOT DELIVERING THE BOLUSES AND THEY WERE NOT RECORDED IN THE INSULIN PUMP MEMORY. IT WAS STATED THAT THE MOTHER REFUSES TO LET THE INSULIN WARM UP TO ROOM TEMPERATURE, AND IT BUILD UP A CONDENSATION IN THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347511 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1