BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT MMT-1761KES 670G V4.11 JBL MG

    MDR report key: 22002417 · Received May 12, 2025

    Report

    Report Number
    2032227-2025-172695
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 13, 2025
    Report Date
    May 15, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000367657
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 A CRACK IN THE BACK SITE OF THE PUMP, CLOSE TO THE BATTERY COMPARTMENT, AND A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY (PUMP ERROR 35) ALARM. ALSO, THE CUSTOMER REPORTED THE CRITICAL PUMP ERROR AND OTHER CRITICAL PUMP ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1761KES. TROUBLESHOOTING WAS PERFORMED, AND THE CRACK WAS IMPACTED THE PUMP'S FUNCTIONALITY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1761KES WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465896 KIT MMT-1761KES 670G V4.11 JBL MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1761KES HG5AYDJ 000000763000367657

    Patients

    Seq Age Sex Outcome Treatment
    1