BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 16066301 · Received December 29, 2022

    Report

    Report Number
    2032227-2022-390588
    Event Type
    Death
    Date Received
    December 29, 2022
    Date of Event
    November 25, 2020
    Report Date
    December 29, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INSULIN 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. THERE WAS NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, FADED SERIAL NUMBER LABEL, 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 DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE PUMP HISTORY FILE. THE PUMP HISTORY FILE LISTS DATA FROM NOVEMBER 22, 2018 TO MARCH 11, 2019. THERE WAS NO DATA LISTED ON THE EVENT DATE NOVEMBER 25, 2020 AND ON THE 7 DAYS PRIOR TO THAT DATE. THE PUMP PASSED THE FUNCTIONAL TESTING. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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 ON (B)(6) 2020. THE CAUSE OF DEATH WAS UNKNOWN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199417 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death