BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET, INFUSION SET

    MDR report key: 9102726 · Received September 23, 2019

    Report

    Report Number
    3003442380-2019-00007
    Event Type
    Death
    Date Received
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006492
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED FAILURE CANNOT BE CONFIRMED. NO LOT NUMBER REPORTED AND NO DEVICE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER: (B)(4). WIFE REPORTED THAT MALE DIABETIC PATIENT ON PUMP THERAPY HAS PASSED AWAY. REPORTED INFUSION SET TUBING KINKED AND HIS BLOOD SUGARS WENT TO OVER 1000 MG/DL BY THE TIME HE THEY GOT TO HOSPITAL HE WAS IN DKA AND PASSED AWAY SHORTLY AFTER. DATE OF HOSPITALIZATION AND DEATH UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899201 QUICK-SET, INFUSION SET QUICK-SET FPA UNOMEDICAL A/S MMT-387 UNKNOWN 05705244006492

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H