BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET

    MDR report key: 1721694 · Received June 8, 2010

    Report

    Report Number
    8021545-2010-00005
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    March 10, 2009
    Report Date
    May 31, 2010
    Product Code
    FPA
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S HAS NOT RECEIVED ANY USED OR UNUSED PRODUCT, THEREFORE, AN INVESTIGATION OF THE PRODUCT COULD NOT BE CONDUCTED. IF THE INVOLVED DEVICE OR DEVICES FROM THE SAME LOT IS RETURNED FOR EVAL, A FOLLOW UP REPORT WITH RELEVANT FINDINGS WILL BE SUBMITTED. IN THE RECEIVED COMPLAINT NO LOT NUMBER WAS AVAILABLE, NOR WAS THERE ANY INFO REGARDING DETAILS OF EVENT INCLUDING ALARM HISTORY OF PUMP. THE PRODUCT RECALL NOTIFICATION WAS NOT ISSUED UNTIL JUNE 2010. (B) (4).

    Description of Event or Problem · 1

    INFO RECEIVED FROM DISTRIBUTOR: PT DECEASED, DUE TO DIABETIC KETOACIDOSIS. AT THE TIME OF HER DEATH, PT WAS USING A QUICK SET, INCLUDING "LOT 8". THE PRODUCT HAS BEEN THE SUBJECT OF A FDA RECALL, AFTER A DEFECT RESULTED IN TOO MUCH, OR TOO LITTLE INSULIN BEING DELIVERED TO THE PT. UNFORTUNATELY, THE NOTIFICATION OF THE PRODUCT RECALL DID NOT REACH THE PT BEFORE SHE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET FDA FPA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death