BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS

    MDR report key: 14082350 · Received April 12, 2022

    Report

    Report Number
    2032227-2022-178429
    Event Type
    Death
    Date Received
    April 12, 2022
    Date of Event
    March 16, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169513099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DAT AT 0.0874 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. THE PUMP ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. THE PUMP HAD INTERMITTENT BUTTON RESPONSE ON THE ESC, ACT, UP ARROW AND DOWN ARROW BUTTONS DUE TO FLATTENED DOME SWITCHES (NO CREASE). NO BUTTON ERROR ALARM NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNER, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THDS AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW WHEN REVIEWING THE HISTORY DOWNLOAD. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE DOWNLOAD HISTORY FILE LISTS DATA FROM 08/10/2021 TO 02/01/2022. THERE WAS NO DATA LISTED ON MARCH 2022. THE PUMP PASSED THE FUNCTIONAL TESTING. THE PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCHES (NO CREASE) WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED AWAY ON (B)(6) 2022 AT HOSPICE. THE CAUSE OF DEATH WAS RENAL FAILURE. THE CUSTOMER BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING SENSOR. THE INSULIN PUMP WAS RETURNED FOR THE ANALYSIS. THE CASE WAS REPORTED ON THE BASIS OF FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED AWAY ON (B)(6), 2022 AT HOSPICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682919 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAS A1523RNASJ 000000643169513099

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death