BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15025002 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287107
    Event Type
    Death
    Date Received
    July 15, 2022
    Date of Event
    November 1, 2021
    Report Date
    July 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W 4.11E; RETAINER RING: CLEAR. THE CUSTOMER PASSED AWAY ON (B)(6) 2021 (EVENT DATE) , HOWEVER ON THE CUSTOMER NOTES THE CUSTOMER'S DATE OF PASSING WAS (B)(6) 2021. 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, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND CRACKED RETAINER. 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 WAS RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FORM (B)(6) 2021. THERE WAS NO DATA LISTED ON (B)(6) 2021. THE PUMP PASSED THE FUNCTIONAL TESTING. 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

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2021. THE CAUSE OF DEATH WAS RESPIRATORY FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NO FURTHER INFORMATION WAS GIVEN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS. THE CASE IS REPORTED ON BASIS OF FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349569 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3F7JS 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death FRN-MMT-332A-RSVR, UNOMED SET