BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972255 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88720
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE DEATH WAS 517 MG/DL. IT WAS REPORTED THAT THE CUSTOMER WENT FOR A BIKE RIDE AND WAS EXTREMELY TIRED BY THE END OF THE DAY. ACCORDING TO THE POLICE REPORT THE CUSTOMER WAS FOUND TO BE LAYING DOWN AND UNRESPONSIVE. THE PARAMEDICS AND THE FIRE DEPARTMENT WERE IMMEDIATELY CALLED AND THE CUSTOMER WAS DEAD ON ARRIVAL. THE CAUSE OF THE DEATH WAS REPORTED TO BE DIABETIC KETOACIDOSIS AND CORONARY ARTERY DISEASE. THE INSULIN PUMP IS REQUESTED TO BE RETURNED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447628 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death