BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP

    MDR report key: 6093962 · Received November 10, 2016

    Report

    Report Number
    2032227-2016-41399
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 30, 2016
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH AN ENERGIZER ALKALINE BATTERY INSTALLED. THE PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR AND DISPLACEMENT TESTS. THE PUMP HAD A SCRATCHED CASE. DATA ANALYSIS: THE DOWNLOAD HISTORY FILE LISTS DATA FROM (B)(6) 2016 TO 11/17/2016. ON (B)(6) 2016 DAILY TOTAL OF ALL INSULIN DELIVERED = 14.050 UNITS. ON (B)(6) 2016 DAILY TOTAL OF ALL INSULIN DELIVERED = 14.975 UNITS. ON (B)(6) 2016 DAILY TOTAL OF ALL INSULIN DELIVERED = 18.775 UNITS. ON (B)(6) 2016 DAILY TOTAL OF ALL INSULIN DELIVERED = 17.250 UNITS. ON (B)(6) 2016 DAILY TOTAL OF ALL INSULIN DELIVERED = 6.000 UNITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS DIABETIC COMA. THE CUSTOMER'S LAST RECORDED BLOOD GLUCOSE WAS 370 MG/DL ON (B)(6) 2016 AT 9:09 PM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744633 630G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death