BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3892922 · Received June 24, 2014

    Report

    Report Number
    2032227-2014-03313
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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.

    Description of Event or Problem · 1

    THE WIFE OF THE DECEASED REPORTED THAT THE CUSTOMER PASSED AWAY. THE ONLY BLOOD GLUCOSE READING SHE IS AWARE OF WAS FROM WHEN THE CUSTOMER WENT TO THE HOSPITAL ON SATURDAY, (B)(6), 2004. THE BLOOD GLUCOSE READING AT THAT TIME WAS OVER 600 MG/DL. THE CUSTOMER HAD BEEN VOMITTING AND STATED THAT HE WASN'T FEELING WELL THE NIGHT BEFORE AROUND 11PM. THE CUSTOMER REMOVED HIS PUMP SOME TIME BETWEEN MIDNIGHT AND 11AM THE NEXT DAY. THE WIFE STATED THAT THE CAUSE OF DEATH WAS HIS HEART AND KETOACIDOSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369311 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death