BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6158653 · Received December 9, 2016

    Report

    Report Number
    2032227-2016-49064
    Event Type
    Death
    Date Received
    December 9, 2016
    Date of Event
    September 14, 2016
    Report Date
    December 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN THE EMERGENCY ROOM. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE CALLER STATED THAT THE CUSTOMER WAS NOT HOSPITALIZED; JUST WENT TO THE EMERGENCY ROOM. THE CUSTOMER HAD END STAGE RENAL DECEASE, DIABETES COMPLICATIONS, HEART DISEASE, AND INFECTION. THE CUSTOMER WAS IN SEPTIC STATES, HAD A PACEMAKER BUT DID NOT HAVE IT CHECKED OR MAINTAINED. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS LOW AT THE TIME OF PASSING; THE CALLER COULD NOT RECALL THE EXACT VALUE. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT HAD BEEN REMOVED THIRTY MINUTES PRIOR TO PASSING. THE CALLER DID NOT KNOW WHETHER OR NOT THE CUSTOMER WAS USING SENSORS. THE CALLER STATED THAT THEY NO LONGER HAVE THE CUSTOMER'S INSULIN PUMP; IT HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813969 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death