BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 22041986 · Received May 19, 2025

    Report

    Report Number
    2032227-2025-176591
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    February 12, 2025
    Report Date
    May 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. THE PUMP WAS RECEIVED WITH A SCRATCHED CASE. THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 WITHIN SPECIFICATION AT 0.08715 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN# (B)(6) EVENT DATE OF 12-FEB-2025, THERE IS NO UNEXPECTED ALARMS/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. ON THE PRIMARY SVN# (B)(6) EVENT DATE OF 12-FEB-2025 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 18 U AND DAILYTOTALOFBOLUSINSULINDELIVERED = 7 U WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 25 U. ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE, THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE PRIMARY SVN# (B)(6) EVENT DATE OF 12-FEB-2025. 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. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE RELATED SVN#: (B)(6) EVENT DATE OF 24-DEC-2024, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 06:01:25.000, (B)(6) 2024 06:02:12.000; (B)(6) 2024 06:02:34.000, (B)(6) 2024 06:02:38.000; (B)(6) 2024 21:17:44.000, (B)(6) 2024 21:20:03.000; (B)(6) 2024 21:20:05.000; LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2024 05:59:00.000; FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2024 06:02:33.000, (B)(6) 2024 06:02:34.000; (B)(6) 2024 21:17:44.000, (B)(6) 2024 21:20:04.000; (B)(6) 2024 21:30:00.000; PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2024 21:31:03.000; POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 21:31:20.000; (B)(6) 2024 21:31:31.000. 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) 2025 AT 7:00:00 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF (B)(6) 2024 AND (B)(6) 2024. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM. NO UNEXPECTED LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. 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 (22.93 MV). THE PUMP WAS RECEIVED WITH A DEPLETED HDX ALKALINE BATTERY INSTALLED. THE PUMP WAS RECEIVED WITH A BATTERY CAP WITH A LOOSE METAL CONTACT DUE TO A BROKEN THREE HEAT STAKE POST. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A BROKEN BELT CLIP RAILS. COSMETIC DAMAGE WAS CONFIRMED. CUSTOMER ALLEGED FOR BLANK DISPLAY WAS NOT CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. HOWEVER, BATTERY CAP CONTACT MISSING/DAMAGED 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 WAS PASSED AWAY DUE TO HEART ATTACK IN THE HOSPITAL ON (B)(6) 2025. THE EVENT INVOLVED PRODUCT(S) MMT-1715KL, MMT-332A, UNOMEDICAL. TROUBLESHOOTING WAS PERFORMED TO GET THE CUSTOMER DECEASED INFORMATION FROM WIFE. PUMP WORN AT THE TIME OF PASSING. MMT-1715KL WAS REQUESTED AND RETURNED FOR PRODUCT ANALYSIS. NO PRODUCT RETURN REQUIRED FOR MMT-332A. NO PRODUCT RETURN REQUIRED FOR UNOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143552 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5HKLU 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male