BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2202366 · Received August 2, 2011

    Report

    Report Number
    2032227-2011-01915
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 HIGH BLOOD GLUCOSE. THE NURSE STATED THAT THE MOTHER AND THE CUSTOMER NEED MORE TRAINING ON THE INSULIN PUMP. ADVISED THE NURSE THAT THE CUSTOMER NEEDS TO CALL BACK REGARDING THE CUSTOMER'S HOSPITALIZATION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization