BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090087 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81354
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 700MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE LEVEL FOR THE PAST FIVE DAYS. CUSTOMER'S MOST RECENT GLUCOSE READING WAS 397MG/DL. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME AND SELF TEST AND THE DEVICE PASSED THE TESTS. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization