BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 18796131 · Received February 28, 2024

    Report

    Report Number
    2032227-2024-133631
    Event Type
    Death
    Date Received
    February 28, 2024
    Date of Event
    January 29, 2024
    Report Date
    May 20, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000166519
    PMA / PMN Number
    P150001
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN ADDED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. 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 0.08740 INCHES. THE PUMP WAS MONITORED AND NO PUMP ERROR 63 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 27-SEP-2021, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 27-SEP-2021 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = 09/27/2021 10:39:01.000. DAILYTOTALOFALLINSULINDELIVERED = 22.325. DAILYTOTALOFBASALINSULINDELIVERED = 8.325. DAILYTOTALOFBOLUSINSULINDELIVERED = 14. 09/27/2021 12:14:30.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS, NORMALBOLUSAMOUNTPROGRAMMED = 7, BOLUSAMOUNTDELIVERED = 7. 09/27/2021 17:20:50.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS, NORMALBOLUSAMOUNTPROGRAMMED = 7, BOLUSAMOUNTDELIVERED = 7. 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. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 27-SEP-2021 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/27/2021 10:37:16.000, 09/27/2021 10:37:51.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/27/2021 10:34:33.000, 09/27/2021 10:34:58.000, 09/27/2021 10:35:05.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 12-JAN-2022 AT 8:05:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 27-SEP-2021. UNABLE TO CHECK POWER DATA FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED DURING TESTING. PUMP ERROR 63 ALARM (VARIABLEINFO = 03) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 09/27/2021 10:34:30.000. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND FOUND A BROKEN TRACE ON U1 KEYPAD ASSEMBLY. PUMP ERROR 63 ALARM (VARIABLEINFO = 03) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO A BROKEN TRACE ON U1 KEYPAD ASSEMBLY. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 04/04/2019 TO 01/25/2022. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARMS/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATES OF 28-SEP-2023 AND 29-JAN-2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATES OF 28-SEP-2023 AND 29-JAN-2024 IN THE FORMATTED HISTORY FILE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (21.6MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. 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 CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THERE WAS NO DATA AVAILABLE TO VERIFY CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE OF 29-JAN-2024 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. RETAINER RING DAMAGE (A CRACKED RETAINER) WAS CONFIRMED. PUMP ERROR 63 ALARM (VARIABLEINFO = 03) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO A BROKEN TRACE ON U1 KEYPAD ASSEMBLY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 600 MG/DL AT THE TIME OF THE HOSPITALIZATION AND THE CUSTOMER PASSED AWAY ON (B)(6) 2023. THE CUSTOMER HAS NOT WORN THE PUMP AT THE TIME OF PASSING AND IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CAUSE OF DEATH WAS DUE TO CONGESTIVE HEART FAILURE. THE BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS 600 MG/DL. THE CUSTOMER WAS NOT USING A SENSOR AT THE TIME OF THE DECEASED EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741628 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG36N2Y 000000763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| D| H FRN-MMT-332A-RSVR, UNOMED INF SET