BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC QUICK-SET INFUSION SET

    MDR report key: 1517376 · Received September 11, 2009

    Report

    Report Number
    1517376
    Event Type
    Death
    Date Received
    September 11, 2009
    Date of Event
    June 10, 2009
    Report Date
    September 9, 2009
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A MALE, DURING RECALL LOOK-BACK DATED IN 2009, ON MEDTRONIC QUICK-SET INFUSION SETS, IT WAS DISCOVERED THAT PT HAD EXPIRED ONE MONTH PRIOR. DEATH CERTIFICATE LISTED CAUSE OF DEATH AS ASYSTOLE, AMI, CAD, HYPERTENSION. IT WAS DISCOVERED THAT PT HAD BEEN DISPENSED TWO SETS OF TUBING FROM AFFECTED LOTS IN 2008 AND IN 2009 PRIOR TO THE RECALL NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK-SET INFUSION SET INFUSION SET FPA MEDTRONIC MINIMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death MINIMED PARADIGM INSULIN PUMP