BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123161 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01433
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 TAKEN TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD A BLOOD GLUCOSE OF 65 MG/DL AT HOME. AFTER RECEIVING TWO GLUCAGON INJECTIONS, THE CUSTOMER'S BLOOD GLUCOSE READING IN THE EMERGENCY ROOM WAS 260 MG/DL. THE FATHER STATED THAT THE CUSTOMER WAS ALSO HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2010. THE CUSTOMER REQUIRED A GLUCAGON INJECTION AT THAT TIME ALSO, AND HIS BLOOD GLUCOSE READING IN THE EMERGENCY ROOM WAS 165 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. ADVISED THE FATHER THAT THE INSULIN PUMP IS FUNCTIONING PROPERLY, BUT OFFERED A REPLACEMENT FOR PEACE OF MIND. THE FATHER DECLINED AT THIS TIME. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization