BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1811893 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82549
    Event Type
    Death
    Date Received
    August 18, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED TWO WEEKS AGO WHILE WEARING THE INSULIN PUMP. IT WAS REPORTED THAT THE CUSTOMER'S DEATH WAS PRONOUNCED BY THE POLICE AT THE CUSTOMER'S HOME. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD A HYPOGLYCEMIC REACTION AT WORK THREE DAYS BEFORE THE EVENT. THE WIFE STATED THAT SHE DOES NOT KNOW IF IT IS DEVICE RELATED. REQUESTED TO RETURN THE DEVICE FOR FURTHER INVESTIGATION. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death