BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21794578 · Received April 8, 2025

    Report

    Report Number
    2032227-2025-150820
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 400 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE EVENT INVOLVED PRODUCT MMT-1761KES. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND LATER CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1761KES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584954 KIT MMT-1761KES 670G V4.11 JBL MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1761KES NG3411053H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other FRN-MMT-332A-RSVR, UNOMED SET