BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 1142768 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01451
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    May 24, 2008
    Report Date
    August 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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 HAD A LOW BLOOD GLUCOSE READING OF 45 MG/DL BEFORE BED TIME. THE CUSTOMER ALSO STATED THAT HIS WIFE NOTICED A COLD SWEAT AND WAS UNABLE TO WAKE HIM UP AND CALLED THE PARAMEDICS. THE PARAMEDICS TREATED HIM WITH GLUCOSE AT HOME. THE CUSTOMER RECOVERED COMPLETELY AND WAS NOT TRANSPORTED TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    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 Required Intervention