BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 16542951 · Received March 15, 2023

    Report

    Report Number
    2032227-2023-170553
    Event Type
    Death
    Date Received
    March 15, 2023
    Date of Event
    April 8, 2019
    Report Date
    April 17, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0873 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. THE PUMP HISTORY FILE LISTS DATA FROM 02/11/2019 TO 03/31/2019, FROM 03/02/2012 TO 04/15/2012 AND THEN FROM 04/18/2019 TO 05/17/2019 03/31/2019 08:04:43.000 USERTIMEDATECHANGE OLDSYSTEMTIME = 03/31/2019 08:04:43.000, NEWSYSTEMTIME = 03/02/2012 19:47:43.00., 04/15/2012 15:19:04.000 USERTIMEDATECHANGE OLDSYSTEMTIME = 04/15/2012 15:19:04.000, NEWSYSTEMTIME = 04/18/2019 19:30:04.000. UNABLE TO LIST THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE 08-APR-2019 AND THE 7 DAYS PRIOR TO THE EVENT DATE DUE TO NO DATA AVAILABLE IN THE FORMATTED HISTORY FILE. THERE WAS NO DATA AVAILABLE FOR THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 08-APR-2019 IN THE FORMATTED HISTORY FILE. HOWEVER, PER CUSTOMER'S NOTES, DATE OF CUSTOMER PASSING: MAY 08, 2019. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE DATE MAY 08, 2019, LISTED IN THE CUSTOMER NOTES ON SMARTSOLVE AND THE DAYS PRIOR TO THAT DATE. 05/02/2019 DAILYTOTALOFALLINSULINDELIVERED = 32.325, 05/03/2019 DAILYTOTALOFALLINSULINDELIVERED = 26.55, 05/04/2019 DAILYTOTALOFALLINSULINDELIVERED = 31.8, 05/05/2019 DAILYTOTALOFALLINSULINDELIVERED = 22.675, 05/06/2019 DAILYTOTALOFALLINSULINDELIVERED = 27.175, 05/07/2019 DAILYTOTALOFALLINSULINDELIVERED = 22.575, 05/08/2019 DAILYTOTALOFALLINSULINDELIVERED = 17.225. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE DATE MAY 08, 2019, IN THE FORMATTED HISTORY FILE. 05/04/2019 03:45:45.000 ALARMALERTNOTIFICATION FAULTNUMBER = SENSOR ERROR ALERT (801) 05/04/2019 06:38:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780) 05/04/2019 07:31:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780) 05/04/2019 07:41:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780) 05/04/2019 08:10:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 2 ALERT (781) 05/04/2019 08:20:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 2 ALERT (781) 05/04/2019 09:11:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = SENSOR SIGNAL NOT FOUND ALERT (796). THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, SENSOR ERROR ALERT, LOST SENSOR ALERT. OR SENSOR SIGNAL NOT FOUND ALERT NOTED DURING TESTING. SENSOR ERROR ALERT NOT CONFIRMED. LOST SENSOR ALERT NOT CONFIRMED. SENSOR SIGNAL NOT FOUND ALERT NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. 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.

    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. 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. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER PASSED AWAY AT HOSPITAL ON (B)(6) 2019. THE CAUSE OF DEATH WAS HEART FAILURE AND KIDNEY FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 0 DUE TO KIDNEY FAILURE. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING SENSORS. THE INSULIN PUMP WILL BE RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016180 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2URFK 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death| R| H FRN-MMT-332A-RSVR, UNOMED SET.