BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2172493 · Received June 17, 2011

    Report

    Report Number
    2032227-2011-01451
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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 EXPERIENCED BLOOD GLUCOSE LEVELS AS HIGH AS 29 MMOL/L. THE CUSTOMER CHANGED THE INFUSION SET, BUT CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. HOWEVER, IT WAS STATED DAYS LATER THAT THE CUSTOMER CONTINUED TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER FELT THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN CORRECTLY. THE HIGH PRESSURE WAS CONDUCTED AGAIN, AND THE INSULIN PUMP FAILED THE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1