BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4233542 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48790
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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. 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 INSULIN PUMP WAS NOT RECEIVED WITH A BATTERY IN THE BATTERY TUBE. A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TESTS. NO DATA ANALYSIS COULD BE PERFORMED DUE TO THE INSULIN PUMP NOT BEING RETURNED WITH A BATTERY IN THE BATTERY TUBE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED THAT THE CUSTOMER PASSED AWAY APPROXIMATELY FOUR MONTHS PRIOR TO THE CALL. CALLER REPORTED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL IN DIABETIC KETOACIDOSIS AND PASSED AWAY FOUR DAYS LATER. CALLER STATED THAT THE CUSTOMER DEVELOPED A DI, BRAIN STEM DAMAGE, AND BLOOD ON THE BRAIN. CALLER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH AS IT WAS REMOVED FOUR DAYS EARLIER IN THE EMERGENCY ROOM. CALLER REPORTED THAT THE CUSTOMER WAS TAKEN FROM THE EMERGENCY ROOM TO THE HEART CATHETERIZATION LAB, WHERE SHE WAS PUT INTO A MEDICALLY INDUCED COMA. CALLER STATED THAT THE CAUSE OF DEATH WAS A DI AND BRAIN STEM INJURY. LAST BLOOD GLUCOSE LEVEL WAS NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715774 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death