BEUDAMED
    FDA Adverse Event Death Summary report: N

    TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC

    MDR report key: 8611704 · Received May 15, 2019

    Report

    Report Number
    2032227-2019-04144
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    February 27, 2016
    Report Date
    May 15, 2019
    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 IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED IN (B)(6) 2014. THE CAUSE OF DEATH WAS A BACTERIAL INFECTION. THE CALLER STATED THAT THE CUSTOMER HAD AN INFECTION, PRESSURE, AND AN ULCER THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF ADMISSION. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING AT THE TIME OF ADMISSION. THE CUSTOMER WAS TAKEN OFF THE PUMP AS THEIR BLOOD GLUCOSE WAS OUT OF CONTROL. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406689 TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death FRN-UNK-RSVR UNOMED SET