BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2133689 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01398
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 700 MG/DL. THE CUSTOMER STATED THAT HE CHANGED THE INFUSION SET, AND GAVE A MANUAL INJECTION, BUT CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS. ADVISED THE CUSTOMER THAT INSULIN MAY HAVE BEEN DENATURED. NO TROUBLESHOOTING WAS DONE ON THE INSULIN PUMP. 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-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization