BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6166934 · Received December 12, 2016

    Report

    Report Number
    2032227-2016-49217
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING THE IDLE CURRENT MEASUREMENT, RUN CURRENT MEASUREMENT, SELF TEST, OFF NO POWER, UNEXPECTED RESTART, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME, REWIND AND EXCESSIVE NO DELIVERY ALARM TESTS. THE PUMP WAS RECEIVED WITH NO BATTERY INSTALLED. THE PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP, A STAINED END CAP STICKER AND MINOR SCRATCHES ON THE LCD WINDOW. DATA ANALYSIS: (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(4) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS, (B)(6) 2016 DAILY INSULIN TOTAL = (B)(6) UNITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CALLER STATED THAT THE CAUSE OF DEATH WAS LUNG CANCER AND KETOACIDOSIS, BUT IT IS NOT COMPLETELY SURE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016 UNTIL (B)(6) 2016, THEN CAME HOME, WENT BACK TO THE EMERGENCY ROOM ON (B)(6) 2016 AFTER WHICH HE DID NOT COME HOME; WAS IN A REHABILITATION CENTER. THE CUSTOMER HAD STAGE FOUR LUNG CANCER AND WAS HAVING BREATHING DIFFICULTIES. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE LAST RECORDED VALUE WAS 345 MG/DL ON (B)(6) 2016 AT 9AM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817976 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death