BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6058444 · Received October 26, 2016

    Report

    Report Number
    2032227-2016-34452
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    September 24, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RETURNED WITH A DEPLETED ENERGIZER ALKALINE BATTERY INSTALLED. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. NO BOLUS ANOMALY OR BASAL ANOMALY NOTED DURING TESTING. THE INSULIN PUMP WAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. DATA ANALYSIS: (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: DATA ANALYSIS: (B)(6) 2016 DAILY INSULIN TOTAL = 24.200U; (B)(6) 2016 DAILY INSULIN TOTAL = 17.550U. THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CAUSE OF DEATH WAS HYPOGLYCEMIA. THE CALLER STATE THAT THE CUSTOMER WAS INTOXICATED AND HAD BLOOD GLUCOSE OF 300 MG/DL. A RELATIVE HELPED THE CUSTOMER TO PERFORM A SET CHANGE AND DELIVERED THREE UNITS OF INSULIN. IN THE MORNING, WHEN THE CUSTOMER WAS FOUND, THE RESERVOIR WAS EMPTY. THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM; THE CUSTOMER'S BLOOD GLUCOSE WAS LESS THAN 10 MG/DL. THE LAST RECORDED BLOOD GLUCOSE VALUE WAS 305 MG/DL ON (B)(6) 2016 AT 10:26PM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE SENSOR WAS TURNED OFF. HOWEVER, THE SENSOR SETTINGS WERE SET UP IN THE CUSTOMER'S INSULIN PUMP. THE CORONER REQUESTED FUNCTIONAL CHECK OF THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED BY THE CUSTOMER'S DIABETES CARE MANAGER AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CORONER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709225 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death