BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 18568134 · Received January 23, 2024

    Report

    Report Number
    2032227-2024-113227
    Event Type
    Death
    Date Received
    January 23, 2024
    Date of Event
    September 15, 2023
    Report Date
    January 23, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08700 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM ON (B)(6) 2023. THERE WAS NO DATA AVAILABLE TO VERIFY NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM AND UNEXPECTED ALARMS/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATE OF 01-FEB-2022. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATE 01-FEB-2022 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 15-SEP-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 15-SEP-2023 LISTED ON SMARTSOLVE. DAILY TOTAL COLLECTION STARTTIME = ON (B)(6) 2023 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED = 32.4. DAILY TOTAL OF BASAL INSULIN DELIVERED = 22.4. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 10. ON (B)(6) 2023 04:52:34.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.7. BOLUS AMOUNT DELIVERED = 1.7. ON (B)(6) 2023 09:39:26.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 3. BOLUS AMOUNT DELIVERED = 3. ON (B)(6) 2023 10:18:51.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 0.3. BOLUS AMOUNT DELIVERED = 0.3. ON (B)(6) 2023 10:46:42.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 5. BOLUS AMOUNT DELIVERED = 5. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 15-SEP-2023 IN THE FORMATTED HISTORY FILE. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT; HOWEVER, A CRACKED RETAINER WAS NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE 15-SEP-2023 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 31.075. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 26.1. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 32.4. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 36. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 29.9. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 32.4 ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 37.65. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 31.4. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 34.2. ON (B)(6) 2023 DAILY TOTAL OF ALL INSULIN DELIVERED = 32.4. RETAINER RING DAMAGE (A CRACKED RETAINER) WAS CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. 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 HOME ON (B)(6) 2023. THE CUSTOMER WAS ADMITTED TO A HOSPITAL PRIOR TO THE REPORTED INCIDENT. THE CAUSE OF DEATH WAS DUE TO LUNG FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 4 MMOL/L. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE INSULIN PUMP WAS RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016996 PUMP MMT-1782K 670G V4.11 MM AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG39Z46 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Death