BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2081302 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-81223
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 347 MG/DL. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS THE NIGHT BEFORE AND THE MORNING OF THE EVENT. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER USES MODEL MMT-943 MIO INFUSION SET, CHANGES HIS SET EVERY TWO TO THREE DAYS, AND LAST CHANGED HIS INFUSION SET RIGHT BEFORE THE EVENT. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TESTS. 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 PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization