BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 1941799 · Received December 22, 2010

    Report

    Report Number
    2032227-2010-83520
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    February 1, 2009
    Report Date
    December 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. PLEASE ALSO SEE MFR REPORT NUMBER 2032227-2010-83525.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS OF APPROXIMATELY 20 MG/DL THE HUSBAND HAD NO FURTHER INFO ON THE EVENT.

    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 33 YR Hospitalization