BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 21846638 · Received April 16, 2025

    Report

    Report Number
    2032227-2025-155049
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 26, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF-TEST. THE HISTORY WAS DOWNLOAD SUCCESSFULLY USING THUS SOFTWARE. THE HISTORY WAS DOWNLOAD SUCCESSFULLY USING THUMPS SOFTWARE. THE LONG TRACE HISTORY FILE CONFIRM PUMP ERROR 4 ALARM ON (B)(6) 2025 07:02:01:000 PM, PUMP ERROR 49 ON (B)(6) 2025 07:27:04:000 PM, PUMP ERROR 68 ON (B)(6) 2025 07:27:04:000 PM AND PUMP ERROR 36 ALARM NOTED ON (B)(6) 2025 07:27:02:000 PM VARIABLE 15 DUE TO MOISTURE DAMAGE ON ELECTRONICS ASSEMBLY. HOWEVER, NO PUMP ERROR 23 ALARM NOTED DURING LONG HISTORY FILES. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. UNIT RECEIVED WITH DAMAGE KEYPAD OVERLAY TEXTURE. AND FADING SERIAL NUMBER LABEL. UNIT WAS CONFIRMED FOR PUMP ERROR 4, 49, 63 AND 68 ALARM DUE TO MOISTURE DAMAGE. HOWEVER, NO PUMP ERROR 23 ALARM NOTED DURING LONG HISTORY FILES. 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 EXPERIENCED THE CUSTOMER RECEIVED PUMP ERROR 4 (THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM.), THE CUSTOMER RECEIVED PUMP ERROR 63 (HARDWARE LOW LEVEL FAILURES.), THE CUSTOMER RECEIVED PUMP ERROR 68 (TRACE POINTERS ARE INVALID.), THE CUSTOMER RECEIVED PUMP ERROR 49 (HISTORY POINTERS FAILED. THE HISTORY POINTERS ARE CORRUPTED.), THE CUSTOMER RECEIVED PUMP ERROR 23 (POST-RESET RAM CRC ALARM). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1780KPK. TROUBLESHOOTING WAS PARTIALLY PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR AND WAS ABLE TO COMPLETE THE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1780KPK WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106545 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG49C7F

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male