BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 1841120 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82660
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    December 1, 2008
    Report Date
    August 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    THE FOLLOWING INFO WAS REPORTED BY THE CUSTOMER'S ATTORNEY: IN OR AROUND (B)(6) OF 2008, CUSTOMER EXPERIENCED SOME SIGNIFICANT BLOOD SUGAR PROBLEMS AND/OR IRREGULARITIES AND WAS HOSPITALIZED ON THREE SEPARATE OCCASIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization