BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4212391 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-42170
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 HAD HIGH BLOOD GLUCOSE LEVELS OF 30 MMOL/L. IT WAS REPORTED THAT THE CUSTOMER WAS FEELING SICK AND COULD NOT TROUBLESHOOT THE HIGH BLOOD GLUCOSE LEVELS. DURING BOLUS, THE CUSTOMER NOTICED THAT THE RESERVOIR WAS NOT MAKING THE USUAL NOISE .THE INSULIN PUMP WAS VISUALLY CHECKED BUT THERE APPEARS TO BE NO APPARENT DAMAGE. IT ALSO APPEARED THAT INSULIN DID EXIT WITH MANUAL PRIME. THE CUSTOMER REPORTED A BENT CANNULA WHEN THE INFUSION SET WAS CHANGED. IT WAS REPORTED THAT THE CUSTOMER WAS INSERTING THE INFUSION SET AT THE SIDE OF THE LEG. FURTHER TROUBLESHOOTING ALSO REVEALED THAT THE INSULIN PUMP HAD FAILED A MOTOR DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680900 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-554CMS

    Patients

    Seq Age Sex Outcome Treatment
    1