BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1678436 · Received May 7, 2010

    Report

    Report Number
    3004209178-2010-81204
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    March 8, 2010
    Report Date
    April 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS CARDIAC ARRHYTHMIA CONGESTIVE HEART FAILURE END-STAGE RENAL DISEASE, DUE TO UNCONTROLLED DIABETES. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. PRIOR TO THE EVENT, THE CUSTOMER'S WIFE FOUND HIM UNCONSCIOUS. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 33 MG/DL. THE CUSTOMER WAS TAKEN BY PARAMEDICS TO THE HOSPITAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death