BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3801247 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84469
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. MEDTRONIC

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP DID NOT GET THE NO DELIVERY ALARM AND THE BATTERY LASTED ONLY FOR A FEW DAYS. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 15.7MMOL/L AND HAD LOST CONFIDENCE IN THE DEVICE. THE CALLER MENTIONED THAT THE INFUSION SET WAS CHANGED THREE TIMES. ASSISTED THE CUSTOMER TO RUN THE HIGH PRESSURE TEST AND THE TEST FAILED TWICE. INITIALLY, IT WAS REPORTED THAT THE DEVICE WAS DOING WEIRD THINGS WHEN BOLUSING. THE CALLER STATE THAT THEY CALLED FROM THE SCHOOL AND THE CUSTOMER'S BLOOD GLUCOSE WAS 27MMOL/L. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278645 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAP

    Patients

    Seq Age Sex Outcome Treatment
    1