BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-515LNAB

    MDR report key: 1962819 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00108
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 380 MG/DL. THE MOTHER HAD NO FURTHER INFO ABOUT THE EVENT, AND THE CUSTOMER WAS NOT AVAILABLE FOR TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-515LNAB INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization