BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET INFUSION SET

    MDR report key: 1595266 · Received January 26, 2010

    Report

    Report Number
    MW5014636
    Event Type
    Death
    Date Received
    January 26, 2010
    Date of Event
    March 10, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I REPRESENT THE ESTATE OF (B) (6). MRS (B) (6) DIED ON (B) (6) 2009, AS THE RESULT OF DIABETIC KETOACIDOSIS. AT THE TIME OF HER DEATH, SHE WAS USING A QUICK-SET INFUSION SET MFG BY MEDTRONIC MEDICAL PRODUCTS, INC., "LOT-8". THE PRODUCT HAS BEEN THE SUBJECT OF AN FDA RECALL, AFTER IT WAS DISCOVERED THAT A DEFECT RESULTED IN TOO MUCH, OR TOO LITTLE, INSULIN BEING DELIVERED TO THE PT. UNFORTUNATELY, NOTIFICATION OF THE PRODUCT RECALL DID NOT REACH MRS (B) (6) UNTIL AFTER SHE DIED. WE BELIEVE THAT HER DEATH RESULTED FROM INSUFFICIENT INSULIN BEING DELIVERED TO HER BODY, BECAUSE OF THE PRODUCT DEFECT. IT IS MY UNDERSTANDING THAT THIS MATTER HAS BEEN INVESTIGATED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-SET INFUSION SET NONE FPA MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death