BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2072443 · Received April 22, 2011

    Report

    Report Number
    2032227-2011-00999
    Event Type
    Death
    Date Received
    April 22, 2011
    Date of Event
    November 1, 2010
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THE DEATH OF CUSTOMER. CAUSE OF DEATH WAS REPORTED AS HEART FAILURE AND LOW BLOOD GLUCOSE. CUSTOMER'S WIFE STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. CUSTOMER'S WIFE ALSO REPORTED THAT THE CUSTOMER HAD AN INTENSE EXERCISE AND DID NOT EAT THE DAY HE PASSED AWAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death