BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2914600 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-90262
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED UNEXPLAINED LOW BLOOD GLUCOSE FOR TWO DAYS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING WAS REVIEWED AND FOUND TIME DELAYED BY SEVEN MINUTES. THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. REVIEWED THE BOLUS HISTORY AND FOUND BOLUSES THAT THE CUSTOMER DID NOT PROGRAM. THE MOTHER STATED THAT THE BOLUS WAS PROGRAMMED AND DELIVERED AS CUSTOMER WAS ASLEEP. IT WAS STATED THAT THE CUSTOMER NOTICED TWO DOSES OF INSULIN WITHIN A SHORT PERIOD OF TIME. THE MOTHER MENTIONED THAT THE CUSTOMER HAD AN X-RAY SOMETIMES IN OCTOBER WHILE WEARING THE INSULIN PUMP. THE CALLER ALSO STATED THAT THE CUSTOMER HAD A BAD INFECTION FOR TWO WEEKS. THE MANUAL PRIME TEST WAS PERFORMED AND THE INSULIN DID EXIT. THE HIGH PRESSURE TEST WAS COMPLETED AND PASSED. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21242 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWH

    Patients

    Seq Age Sex Outcome Treatment
    1