BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780X 670G MILLIGRAM

    MDR report key: 25290914 · Received May 26, 2026

    Report

    Report Number
    2032227-2026-177340
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    June 20, 2023
    Report Date
    May 20, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. R, SECKOLD. "A RANDOMIZED CROSSOVER TRIAL COMPARING GLUCOSE CONTROL BETWEEN DIFFERENT EXERCISE TYPES IN ADOLESCENTS WITH TYPE 1 DIABETES USING A HYBRID CLOSED-LOOP SYSTEM." DIABETES (83RD SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION, ADA 2023), 72 SUPPLEMENT 1 , 2023, HTTPS://WWW.EMBASE.COM/RECORDS?ID=L650945155. 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

    IN THE STUDY, "A RANDOMIZED CROSSOVER TRIAL COMPARING GLUCOSE CONTROL BETWEEN DIFFERENT EXERCISE TYPES IN ADOLESCENTS WITH TYPE 1 DIABETES USING A HYBRID CLOSED-LOOP SYSTEM" IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE BLOOD GLUCOSE VALUE DURING THE EVENT WAS 54 MG/DL. THE EVENT INVOLVED PRODUCT MMT-1780X. TROUBLESHOOTING WAS NOT PERFORMED. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCTS WERE RETURNED FOR ANALYSIS AS A RESULT OF THE STUDY'S FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277492 PUMP MMT-1780X 670G MILLIGRAM AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780X

    Patients

    Seq Age Sex Outcome Treatment
    1