BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1710K

    MDR report key: 13923259 · Received March 26, 2022

    Report

    Report Number
    2032227-2022-148392
    Event Type
    Death
    Date Received
    March 26, 2022
    Date of Event
    December 15, 2020
    Report Date
    March 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169554900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W 2.6B; RETAINER RING = CLEAR. ON (B)(6) 2020 THE CUSTOMER PASSED AWAY. 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 0.0875 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE 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 FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 05/13/2015 TO 05/27/2019, ON 12/22/2019 AND ON 12/22/2020. THERE WAS NO DATA LISTED ON THE EVENT DATE. 05/27/2019 18:09:45.000 USER TIME DATE CHANGE. EVENT TYPE = 3; SOURCE ID = PUMP (NGP IS IN OPEN LOOP STATE); HISTORY RECORD LENGTH = 19; OLD SYSTEM TIME = 05/27/2019 18:09:45.000; NEW SYSTEM TIME = 12/22/2019 15:10:46.000; 12/22/2019 15:12:11.000 USER TIME DATE CHANGE; EVENT TYPE = 3; SOURCE ID = PUMP (NGP IS IN OPEN LOOP STATE); HISTORY RECORD LENGTH = 19; OLD SYSTEM TIME = 12/22/2019 15:12:11.000; NEW SYSTEM TIME = 12/22/2020 15:11:11.000. THE PUMP PASSED THE FUNCTIONAL TESTING. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY. NO FURTHER INFORMATION WAS GIVEN DUE TO DATA PROTECTION. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS. THE CASE IS REPORTED ONLY FOR THE F.A RESULTS. ASA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587940 640G INSULIN PUMP MMT-1710K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1710K 000000643169554900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death