BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5721649 · Received June 13, 2016

    Report

    Report Number
    2032227-2016-12420
    Event Type
    Death
    Date Received
    June 13, 2016
    Date of Event
    May 25, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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

    INFORMATION WAS RECEIVED REGARDING THE PASSING OF THE CUSTOMER. THE CALLER WAS THE TERRITORY MANAGER AND HAD LIMITED INFORMATION. IT IS BELIEVED THAT THE CUSTOMER WAS FOUND AT HOME AND THE POSSIBLE CAUSE OF DEATH IS THOUGHT TO BE HYPOGLYCEMIA - LOW BLOOD GLUCOSE; SUSPECTED OVERDOSE FROM THE INSULIN PUMP. PER THE DOWNLOADED INFORMATION FROM THE INSULIN PUMP, WHICH WAS PROVIDED BY THE CUSTOMER'S HEALTH CARE PROFESSIONAL, THE EVENT THAT LED TO THE CUSTOMER'S DEATH BEGAN IN THE EVENING OF (B)(6) 2016. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 AND PASSED AWAY ON (B)(6) 2016. IT IS UNKNOWN WHO IS CURRENTLY IN POSSESSION OF THE CUSTOMER'S INSULIN PUMP - THE CUSTOMER'S FAMILY OR THE CUSTOMER'S HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374402 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death