BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3854817 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85475
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE BOLUS WIZARD FUNCTIONS PROPERLY. THE INSULIN PUMP PROPERLY DELIVERED THE ESTIMATE TOTAL BOLUS COMPLETELY. NO BOLUS ANOMALY OR NO BOLUS WIZARD ANOMALY NOTED DURING TESTING. THE INSULIN PUMP WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. 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 OR BOLUS 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 A SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT DELIVERING INSULIN, AND THE CUSTOMER FELT THE DEVICE WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 22.9MMOL/L AND TREATED WITH BACK UP PLAN. THE CUSTOMER EXPERIENCED KETONES, HEADACHES, AND WAS LETHARGIC. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT NOTED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUN THE HIGH PRESSURE TEST AND THE TEST PASSED. THE CUSTOMER WAS CONCERNED THAT THE BOLUS WIZARD APPEARED TO BE DISCOUNTING INSULIN ON EVERY BOLUS WIZARD DELIVERY, WHICH THEY FELT, MAY BE THE REASON FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333084 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CAB

    Patients

    Seq Age Sex Outcome Treatment
    1