BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 21695945 · Received March 26, 2025

    Report

    Report Number
    2032227-2025-143398
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    November 6, 2022
    Report Date
    March 26, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 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. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 01/01/2009 AND 02/28/2020 TO 08/14/2022. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE DATE OF 14-AUG-2022 LISTED ON PUMP HISTORY AND THE DAYS PRIOR TO THAT DATE. 06/06/2022 DAILYTOTALOFALLINSULINDELIVERED = 76.575 06/07/2022 DAILYTOTALOFALLINSULINDELIVERED = 0.4 06/07/2022 DAILYTOTALOFALLINSULINDELIVERED = 41.675 06/08/2022 DAILYTOTALOFALLINSULINDELIVERED = 91.35 06/09/2022 DAILYTOTALOFALLINSULINDELIVERED = 36.025 06/09/2022 DAILYTOTALOFALLINSULINDELIVERED = 0 08/09/2022 DAILYTOTALOFALLINSULINDELIVERED = 4.4 08/10/2022 DAILYTOTALOFALLINSULINDELIVERED = 66.35 08/11/2022 DAILYTOTALOFALLINSULINDELIVERED = 66.35 08/12/2022 DAILYTOTALOFALLINSULINDELIVERED = 66.35 08/13/2022 DAILYTOTALOFALLINSULINDELIVERED = 66.35 08/14/2022 DAILYTOTALOFALLINSULINDELIVERED = 13.2 THERE IS NO AVAILABLE DATA AFTER 14-AUG-2022. THE PUMP PASSED ALL THE REQUIRED TESTING. 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 ON 06-NOVEMBER-2022. THE CUSTOMER HAD CONGESTIVE HEART FAILURE, TRAUMATIC BRAIN INJURY FROM A FALL, AND THEN A MASSIVE HEART ATTACK AT THE VERY END. THE EVENT INVOLVED PRODUCT(S) MMT-1715K, MMT-397A AND MMT-332A. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS NOT USING THE INSULIN PUMP AT THE TIME OF DEATH AND WAS HOSPITALIZED FOR THE TREATMENT. THE INSULIN PUMP WAS LAST WORN ON (B)(6) 2022. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696054 630G INSULIN PUMP MMT-1715K 630G BLACK MG AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG444PT 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male