BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4140818 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33492
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY A CARDIO PULMONARY ARREST. IT WAS NOTED THAT POORLY MANAGED DIABETES AND A CARDIAC ARREST LEAD UP TO THE DEATH. SISTER STATED THAT THE CUSTOMER WAS ALONE WHEN SHE PASSED AWAY. CUSTOMER WAS FOUND FACE DOWN ON THE BED COLD. THE INSULIN PUMP WAS REQUESTED TO BE RETURNED; HOWEVER, IT WAS NOTED THAT THE INSULIN PUMP WAS CREMATED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620633 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death