BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2081241 · Received April 26, 2011

    Report

    Report Number
    2032227-2011-01024
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 110 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER WAS NOT AVAILABLE TO PERFORM TROUBLESHOOTING AT THE TIME OF THE REPORT. THE CUSTOMER'S MOTHER WAS ADVISED TO CALL BACK WHEN TROUBLESHOOTING CAN BE PERFORMED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization