BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2870053 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07988
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER CALLED TO REPORT ISSUES WITH HIGH BLOOD GLUCOSE LEVELS, AND BEING HOSPITALIZED FOR FOUR DAYS. THE CALL WAS DISCONNECTED WHILE TRYING TO VERIFY THE CUSTOMER'S ACCOUNT INFORMATION. NOTHING FURTHER WAS REPORTED.

    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 Hospitalization