BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1980815 · Received February 7, 2011

    Report

    Report Number
    2032227-2011-00372
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PASSED AWAY AFTER BEING ADMITTED TO THE HOSPITAL WITH ERRATIC BLOOD GLUCOSE LEVELS. AT ONE POINT, THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE AS HIGH AS 68 MMOL/L. IT WAS REQUESTED THAT A COMPANY REPRESENTATIVE GO TO THE HOSPITAL TO DOWNLOAD THE INSULIN PUMP INFORMATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death