BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 513770 · Received March 1, 2004

    Report

    Report Number
    2032227-2004-00291
    Event Type
    Death
    Date Received
    March 1, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 5, 2004
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A MONTH BEFORE THE CUSTOMER'S DEATH A NURSE REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DKA. TROUBSHOOTING WAS NOT PERFORMED AT THE TIME OF CALL. THE DR STATED THAT THE CLIENT HAD A VIRAL INFECTION WHICH POSSIBLY CONTRIBUTED TO THE DKA AND THE CUSTOMER WAS IN COMA. IT WAS INDICATED THAT A CPT INSPECTED THE PUMP AND SHOWED THE CUSTOMER THE PROPER TECHNIQUES. A FEW DAYS LATER IT WAS NOTIFIED THAT THE CUSTOMER PASSED AWAY. MOREOVER, THEIR DR'S NURSE STATED THAT HE HAD NOT SEEN THE CUSTOMER FOR OVER A YEAR AND THEIR FILE IS ARCHIEVED. FURTHERMORE THE FAMILY MEMBER WAS CONTACTED AND DID NOT WANT TO DISCUSS THE INCIDENT. THE FAMILY MEMBER INDICATED THAT THE PUMP WAS IN THEIR POSSESSION AND THE AUTOPSY REPORT INDICATES A POSSIBLE PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-511USB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death