BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6182521 · Received December 16, 2016

    Report

    Report Number
    2032227-2016-50346
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    November 24, 2016
    Report Date
    February 4, 2017
    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

    THE INSULIN PUMP PASSED FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT ACCURACY TEST. THE INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE LIP. THERE IS NO DATA AVAILABLE DUE TO THE INSULIN PUMP NOT BEING RECEIVED WITH A BATTERY INSTALLED.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER AS HOSPITALIZED ON (B)(6) 2016. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS AND CHRONIC HEART FAILURE. THE CALLER STATED THAT THE CUSTOMER HAD DIABETES COMPLICATIONS - WAS BLIND, HAD KIDNEY TRANSPLANT, AND HAD CHRONIC HEART FAILURE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT WAS DISCONNECTED AFTER ARRIVING AT THE HOSPITAL. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831907 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death