BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4898051 · Received July 1, 2015

    Report

    Report Number
    3003442380-2015-00011
    Event Type
    Death
    Date Received
    July 1, 2015
    Date of Event
    June 23, 2013
    Report Date
    July 1, 2015
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RELEVANT TESTING COULD BE PERFORMED. SINCE THE LOT NUMBER WAS NOT AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE COULD NOT BE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. WE HAVE NOT BEEN ABLE TO COLLECT MORE INFORMATION FROM OUR DISTRIBUTOR. NO LOT NUMBER AVAILABLE. HOSPITAL NAME UNK. NO INFORMATION IF THE PATIENT HAD ANY SYMPTOMS UP TO EVENT. DEATH CERTIFICATE NOT AVAILABLE DUE TO HIPPA. AUTOPSY REPORT NOT AVAILABLE DUE TO HIPPA. TOXICOLOGY REPORT NOT AVAILABLE DUE TO HIPPA. NO INFORMATION IF WHETHER THE USED DEVICE WILL BE RETURNED FOR INVESTIGATION. UNOMEDICAL HEREBY CONSIDER THIS CASE TO BE CLOSED.

    Description of Event or Problem · 1

    REPORTER ALLEGES: (B)(6) DIED BETWEEN (B)(6) 2013, AS RESULT OF SEVERE HYPOGLYCEMIA EVENTS CAUSED BY THE ALLEGEDLY MALFUNCTION OF THE INSULIN PUMP AND INFUSION SETS HE HAD BEEN UTILIZING IN (B)(6) 2013. ON OR ABOUT (B)(6) 2013, (B)(6) WAS UTILIZING THE MINIMED INSULIN PUMP AND MEDTRONIC QUICK-SET SETS IN A REASONABLE AND FORESEEABLE MANNER IN AN EFFORT TO MANAGE AND CONTROL HIS DIABETES. ON OR ABOUT THE EVENING OF (B)(6) 2013, (B)(6) WITNESSED NO ISSUES OR COMPLICATIONS WITH (B)(6) IN THE MANAGEMENT OF HIS TYPE 1 DIABETES. ON OR ABOUT THE MORNING OF (B)(6) 2013 (B)(6) WAS FOUND NON RESPONSIVE IN HIS BED BY (B)(6). (B)(6) FIRE DEPARTMENT EMERGENCY SERVICES WAS CONTACTED AND RUSHED TO PROVIDE EMERGENCY HEALTH CARE ON (B)64) 2013. (B)(6) WAS DECLARED DEAD UPON THEIR ARRIVAL. THE TOXICOLOGY REPORT IN (B)(6) AUTOPSY FOUND THAT HE HAD A BLOOD GLUCOSE READING IN HIS VITREOUS FLUID LOWER THAN COULD BE DETECTED. SUCH READINGS ARE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND OVER DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429729 QUICK-SET PARADIGM QUIKC-SET PCC FPA UNOMEDICAL A/S MMT-399 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death