BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 22539823 · Received July 18, 2025

    Report

    Report Number
    2032227-2025-215379
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 19, 2025
    Report Date
    February 24, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C, 20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO CONFIRM BATTERY CAP DAMAGE DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. PUMP WAS RECEIVED WITH A COMPLETELY BROKEN BATTERY TUBE THREADS. UNABLE TO INSERT/LOCK THE BATTERY, VERIFY S.W VERSION AND PERFORM THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT DUE TO A COMPLETELY BROKEN BATTERY TUBE THREADS. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO A COMPLETELY BROKEN BATTERY TUBE THREADS. 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. A TEST CASE WAS USED, INSTALLED THE ORIGINAL PCBA 1, PCBA 2, INTERNAL BATTERY AND MOTOR. USING THE AA 1.5V BATTERY, THE PUMP WAS ABLE TO POWER UP. CONTINUED TO DOWNLOAD HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. 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. LOW BATTERY ALERT WAS FOUND ON: 06/15/2025 01:20:00.000. 06/16/2025 01:50:00.000. INSERT BATTERY ALARM WAS FOUND ON: 06/15/2025 04:46:06.000. 06/15/2025 20:18:43.000. 06/16/2025 01:14:40.000, 06/16/2025 01:58:24.000. 06/16/2025 02:16:24.000 TO 06/16/2025 02:17:05.000. 06/19/2025 05:24:02.000 TO 06/19/2025 19:46:40.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 06/16/2025 01:58:24.000. 06/16/2025 02:08:00.000. POWER LOSS ALARM WAS FOUND ON: 06/19/2025 08:22:13.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A NO POWER BATTERY. POWER LOSS ALARM WAS EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. UNABLE TO TEST FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM DUE TO A COMPLETELY BROKEN BATTERY TUBE THREADS. LOW BATTERY ALERT WAS UNEXPECTED SINCE THE CUSTOMER WAS USING A GOOD BATTERY. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON 06/16/2025 01:50:00 FASTER THAN EXPECTED AT 0.02 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON 06/15/2025 01:20:00 FASTER THAN EXPECTED AT 3.56 DAYS. BATTERY CYCLE 3 RECEIVED THE LOWBATTERYALERT (104) ON 05/12/2025 23:59:00 FASTER THAN EXPECTED AT 0.01 DAYS. WITH REFERENCE TO THE BAAT TOOL INSTRUCTIONS, CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS OR CHARGE/BATTERY LASTS LESS THAN EXPECTED PER THE PUMP HISTORY RECORDS. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 19-JUN-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON 18-JUN-2025 DURING BOLUS/BASAL/PRIME DELIVERIES. UNABLE TO TEST FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM DUE TO A COMPLETELY BROKEN BATTERY TUBE THREADS. UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE/BAAT TOOL, SUSPECTED ON HW. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A STAINED KEYPAD OVERLAY, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL MISSING. UNABLE TO CONFIRM BATTERY CAP DAMAGE DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. BATTERY CAP DAMAGE WAS UNKNOWN. UNABLE TO INSERT/LOCK THE BATTERY, VERIFY S.W VERSION, PERFORM THE REQUIRED TESTING, DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO A COMPLETELY BROKEN BATTERY TUBE THREADS. HOWEVER, A TEST CASE WAS USED, INSTALLED THE ORIGINAL PCBA 1, PCBA 2, INTERNAL BATTERY AND MOTOR. USING THE AA 1.5V BATTERY, THE PUMP WAS ABLE TO POWER UP. CONTINUED TO DOWNLOAD HISTORY FILES AND TRACES USING THUS. UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE/BAAT TOOL, SUSPECTED ON HW. 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 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 RECEIVED A LOW BATTERY ALERT. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1780KPK. TROUBLESHOOTING WAS PERFORMED FOR THE LOW BATTERY ALERT, AND THE CUSTOMER RECEIVED A REPLACE BATTERY ALERT. TROUBLESHOOTING WAS ALSO PERFORMED FOR REPLACE BATTERY ALERT, AND THE CUSTOMER REPORTED BATTERY CAP DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1780KPK WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808321 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG41N7M 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male