BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2823296 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90615
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECENTLY HAS THREE EPISODES OF HIGH BLOOD GLUCOSE, AND THE BLOOD GLUCOSE READING WAS 300-400MG/DL. IT WAS STATED THAT THE BOLUSES WERE SAVED IN BOLUS HISTORY. HOWEVER, THE CUSTOMER DISCONNECTED AT THE QUICK RELEASE, AND THE INSULIN DID NOT DRIP OUT. IT WAS STATED THAT THE CUSTOMER IS AFRAID THAT THE DEVICE IS NOT DELIVERING INSULIN PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1