BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3850042 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-85443
    Event Type
    Death
    Date Received
    June 4, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DURING VISUAL INSPECTION INSULIN PUMP WAS RECEIVED WITH BATTERY INSTALLED AND MINOR SCRATCHES ON DISPLAY WINDOW. TEST BATTERY IS 1.60 VOLTS. INSULIN PUMP PASSED THE SELF TEST, OFF NO POWER TEST, REWIND, BASIC OCCLUSION TEST, ERROR TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. INSULIN PUMP FAILED THE DISPLACEMENT DISPLAYING 0.0 UNITS AT THE END OF THE TRAVEL. CHECKED STATUS SCREEN AND UNITS LEFT WAS DISPLAYED. INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST WITH 98.24 PERCENT ACCURACY. INSULIN PUMP WAS RE-TESTED, DISPLACEMENT TEST WAS OK. INSULIN PUMP FAILED THE DISPLACEMENT TEST DUE TO THE DISPLACEMENT TEST TOOL CAUSING A BUILD UP OF PRESSURE AND LACK OF VENTING IN THE RESERVOIR COMPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY WHILE WEARING THE INSULIN PUMP. INITIALLY, THE SPOUSE CALLED ASKING FOR ASSISTANCE WITH DOWNLOADING THE DEVICE. IT WAS STATED THAT THE CUSTOMER HAD A LOW BLOOD GLUCOSE ALERT BEFORE DINNER, NOTHING MORE THAN THAT. THE HUSBAND FOUND HER IN THE MORNING PASSED OUT. IT WAS STATED THAT THE CAUSE OF DEATH WAS A HYPOGLYCEMIC COMA. ASSISTED THE CALLER TO REVIEW THE BOLUS WIZARD SETTINGS AND BASAL RATES, CONFIRMED THE SETTINGS WERE CORRECT. THE SELF TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325935 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death