BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 22140141 · Received June 4, 2025

    Report

    Report Number
    2032227-2025-185631
    Event Type
    Death
    Date Received
    June 4, 2025
    Date of Event
    January 17, 2023
    Report Date
    June 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THIS IS 2 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 (B)(6) 2023 AT HOME. MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON (B)(6) 2025. MEDTRONIC RECEIVED NOTICE OF A DEVICE/PRODUCT LEGAL HOLD NOTIFICATION, AND THE REPORTER ALLEGES THAT THE USE OF ONE OR MORE MEDTRONIC MINIMED 600 SERIES INSULIN PUMPS WITH A DAMAGED, MISSING, OR BROKEN RETAINER RING CAUSED THE CLAIMANT TO SUFFER PERSONAL INJURIES, AND THE CUSTOMER WAS HOSPITALIZED. THE ALLEGATION DID NOT SPECIFY THE PUMP IDENTIFIER (SERIAL NUMBER) AND THEREFORE ALL 600 SERIES INSULIN PUMPS IN POSSESSION OF THE CLAIMANT, INCLUDING THIS PUMP, ARE CONSIDERED POTENTIALLY WITHIN THE SCOPE OF THE REPORT PENDING CONFIRMATION OF THE AFFECTED SERIAL NUMBER(S). ALL RELATED REPORTS WILL BE UPDATED ACCORDINGLY WHEN AND IF THE AFFECTED SERIAL NUMBER IS IDENTIFIED. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS. IT WAS UNKNOWN WHETHER THE INSULIN PUMP WAS WORN AT THE TIME OF PASSING. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-332A, MMT-1780KL, MMT-1780KPK, UNOMEDICAL. TROUBLESHOOTING WAS NOT PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT, AND IT WAS UNKNOWN WHETHER THE SMARTGUARD/AUTO MODE OF THE INSULIN PUMP WAS USED OR NOT. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1780KL. NO PRODUCT RETURN IS REQUIRED FOR MMT-1780KPK. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993758 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3EN50 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| D FRN-MMT-332A-RSVR, UNOMED SET.