BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6072898 · Received November 2, 2016

    Report

    Report Number
    2032227-2016-34980
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    September 29, 2016
    Report Date
    August 4, 2017
    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

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE IDLE CURRENT MEASUREMENT TEST, RUN CURRENT MEASUREMENT TEST, SELF -TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, REWIND TEST, EXCESSIVE NO DELIVERY TEST AND DELIVERY ACCURACY TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW. DATA ANALYSIS THERE IS NO DATA LISTED FOR THE DATED OF (B)(6) 2016 DUE TO INSULIN PUMP RECEIVED WITHOUT 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4). PLEASE SEE MEDWATCH REPORTS 3004209178-2016-79888, 2032227-2016-23510, 2032227-2016-33035.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN A COMA IN THE HOSPITAL WITH BLOOD GLUCOSE OVER 1000 MG/DL. THE CALLER ASKED THE TERRITORY MANAGER WHEN THEY HAD LAST CONTACTED THE CUSTOMER SO THAT THEY COULD PUT TOGETHER A TIMELINE. THE TERRITORY MANAGER ADVISED THAT THE LAST TIME THEY HAD SPOKEN TO THE CUSTOMER WAS ON (B)(6) 2016. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO CONTACT THE NEXT OF KIN TO OBTAIN FURTHER INFORMATION. A CALL BACK REQUEST LETTER HAS BEEN SENT ON (B)(6) 2016. NO CALL BACK HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723616 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death