BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 8589573 · Received May 8, 2019

    Report

    Report Number
    3003442380-2019-00004
    Event Type
    Death
    Date Received
    May 8, 2019
    Date of Event
    October 13, 2013
    Report Date
    May 8, 2019
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04/03/2019; NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFORMATION WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WOULD HAVE BEEN REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS.   THE COMPLAINT HAS BEEN REVIEWED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND EVALUATES THAT NO FURTHER INVESTIGATION CAN BE PERFORMED BEFORE EITHER USED SAMPLES ARE RECEIVED FOR TESTING OR THE LOT NUMBER IS PROVIDED TO INVESTIGATE A POTENTIAL ORIGIN OF THE PRODUCT FAILURE IN THE DEVICES MANUFACTURING TRACEABILITY DOCUMENTS.

    Description of Event or Problem · 1

    (B)(4). THE BELOW EVENT HAS BEEN REPORTED TO UNOMEDICAL AS A LEGAL CASE. ON THE (B)(6) 2013 A MALE DIABETIC PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA CAUSED BY THE MALFUNCTION OF THE INSULIN PUMP, INSULIN RESERVOIRS AND INSULIN INFUSION SETS HE HAD BEEN UTILIZING, RESULTING IN COGNITIVE IMPAIRMENT, A MOTOR VEHICLE ACCIDENT, SUBSEQUENT INJURIES AND HOSPITALIZATION, AND EVENTUALLY DEATH. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386164 QUICK SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death