BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 18834425 · Received March 5, 2024

    Report

    Report Number
    2032227-2024-136142
    Event Type
    Death
    Date Received
    March 5, 2024
    Date of Event
    October 8, 2021
    Report Date
    March 4, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    S.W VERSION 4.11E. RETAINER RING = CLEAR. CASE TYPE = NGP. THE CUSTOMER PASSED AWAY (DUE TO CARDIAC ARREST) ON (B)(6) 2021. 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 0.08715 INCHES. 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 (B)(6) 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 (B)(6) 2021 LISTED ON SMARTSOLVE. DAILY TOTAL COLLECTION STARTTIME = (B)(6) 2021 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED = 73.25. DAILY TOTAL OF BASAL INSULIN DELIVERED = 37.7. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 35.55. (B)(6) 2021 14:56:54.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 16.85. BOLUS AMOUNT DELIVERED = 16.85. (B)(6) 2021 23:28:46.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 18.7. BOLUS AMOUNT DELIVERED = 18.7. 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 (B)(6) 2021 IN THE FORMATTED HISTORY FILE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:50:12.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2021 16:54:16.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2021 14:37:48.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 20:52:01.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 21:09:14.000. 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 (B)(6) 2021 AT 10:01:02 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6) 2021. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING TESTING. PUMP ERROR 61 (STUCK KEY ALARM) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 14:40:51.000. (B)(6) 2021 18:32:50.000. ALL BUTTONS FUNCTION PROPERLY. NO UNEXPECTED PUMP ERROR 61 (STUCK KEY ALARM) NOTED DURING TESTING. 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, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP WAS RECEIVED WITH A LOOSE METAL CONTACT ON THE BATTERY CAP DUE TO A BROKEN THREE HEAT STAKE POST. THE PUMP WAS RECEIVED WITH A DEPLETED E-CIRCUIT ALKALINE BATTERY INSTALLED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE (B)(6) 2021 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 41.8. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 47.1. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 59.825. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 48.925. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 81.75. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 74.425. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 67.3. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 52.675. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 70.75. (B)(6) 2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 73.25. THE PUMP PASSED ALL THE REQUIRED TESTING. RETAINER RING DAMAGE (A CRACKED RETAINER) WAS CONFIRMED. BATTERY CAP CONTACT MISSING/DAMAGED WAS 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 DUE TO CARDIAC REST. THE BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER PUMP WAS WORN THE PUMP DURING DEATH. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882012 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3KTAG 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death