BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 20106792 · Received August 30, 2024

    Report

    Report Number
    2032227-2024-229362
    Event Type
    Death
    Date Received
    August 30, 2024
    Date of Event
    August 21, 2019
    Report Date
    August 30, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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 0.08710 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 21-AUG-2019, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 21-AUG-2019 LISTED ON SMARTSOLVE. DAILY TOTAL COLLECTION START TIME = 08/21/2019 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED = 39.75. DAILY TOTAL OF BASALI NSULIN DELIVERED = 39.75. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0. 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 ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 21-AUG-2019 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2019 16:31:14.000 TO (B)(6) 2019 20:28:11.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2019 16:31:29.000 TO (B)(6) 2019 16:45:00.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2019 20:28:27.000. 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. 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) 2019 AT 5:09:00 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6) 2019. UNABLE TO CHECK POWER DATA FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM NOTED DURING TESTING. THE TEST 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, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. 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 21-AUG-2019 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 105.475. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 141.75. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 131.15. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 100.4. (B)(6) 2019 16:46:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 0. (B)(6) 2019 20:25:30.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 7.225. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 74.65. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 63.85. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 64.575. (B)(6) 2019 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED = 39.75. THE PUMP PASSED ALL THE REQUIRED TESTING. RETAINER RING DAMAGE (A CRACKED RETAINER) WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY. THE EVENT INVOLVED PRODUCT(S) MMT-1780KPK. TROUBLESHOOTING WAS PERFORMED. THE CAUSE OF PASSING WAS UNKNOWN AND IT WAS UNKNOWN IF THE CUSTOMER USING THE DEVICE AT THE TIME OF PASSING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1780KPK WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795037 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG23BRW

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Death