BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 19189078 · Received April 26, 2024

    Report

    Report Number
    2032227-2024-159304
    Event Type
    Death
    Date Received
    April 26, 2024
    Date of Event
    October 25, 2019
    Report Date
    April 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    PMA / PMN Number
    P150001
    Removal / Correction Number
    Z-0956-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 TEST, 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 THE DAT AT 0.0871 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER RING. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE 25-OCT-2019 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. 10/19/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/20/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/21/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/22/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/23/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/24/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. 10/25/2019 DAILYTOTALOFALLINSULINDELIVERED = 0. THERE WERE NO BOLUSES LISTED ON THE EVENT DATE 25-OCT-2019 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 25-OCT-2019 IN THE PUMP HISTORY FILE. 10/26/2019 00:00:00.000 DAILYTOTALS. DAILYTOTALCOLLECTIONSTARTTIME = 10/25/2019 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED = 0. DAILYTOTALOFBASALINSULINDELIVERED = 0. DAILYTOTALOFBOLUSINSULINDELIVERED = 0. THERE WERE NO AUTO SUSPEND (12) ALARM OR USER SUSPENDED ALARM NOTED IN THE PUMP HISTORY FILE. THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 25-OCT-2019 IN THE PUMP HISTORY FILE. THE PUMP PASSED THE FUNCTIONAL TESTING. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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 HAS PASSED AWAY DUE TO HEART FAILURE. THE EVENT INVOLVED PRODUCT MMT-1780KPK. THE PRODUCT RETURN WAS REQUESTED FOR MMT-1780KPK AND THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871281 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG304D8 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death FRN-MMT-332A-RSVR, UNOMED