BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15093157 · Received July 25, 2022

    Report

    Report Number
    2032227-2022-300257
    Event Type
    Death
    Date Received
    July 25, 2022
    Date of Event
    July 16, 2017
    Report Date
    July 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UNIT NOT RECEIVED STUCK IN MANUFACTURING MODE. THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT 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 TEST AT 0.08710 INCHES. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, DAMAGED (SCRATCHED) DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED RETAINER AND A CORRODED BATTERY TUBE. DATA ANALYSIS: 07/10/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 60.4. 07/11/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 60.2. 07/12/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 58.775. 07/13/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 58.7. 07/14/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 68.3. 07/15/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 59.9. 07/16/2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 72.5. 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 ON OCTOBER 9, 2017. THE CAUSE OF DEATH WAS HEART ATTACK. THE CALLER STATED THAT THE CUSTOMER ALSO HAD HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS USING SENSORS AT THE TIME OF DEATH. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607411 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death