BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 1142781 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01450
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 5, 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 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 FELL ASLEEP ON THE COUCH AND THE BLOOD GLUCOSE LEVEL WAS 41MG/DL WHEN THE PARAMEDICS ARRIVED. THE CUSTOMER WAS TREATED WITH GLUCOSE AND RECOVERED COMPLETELY. IT WAS STATED THAT THE CUSTOMER HAD DINNER AND TOOK 12 UNITS OF NOVOLOG. NO FURTHER INFO 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