BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 24868083 · Received April 14, 2026

    Report

    Report Number
    2032227-2026-159184
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 13, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    QJS
    UDI-DI
    000000763000819385
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 AND ALLEGED FOR INSULIN WAS NOT WORKING CORRECTLY. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 420 MG/DL. THE EVENT INVOLVED PRODUCTS MMT-442AK, UNK_SENSOR AND MMT-1884L. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR HIGH BLOOD GLUCOSE WHICH HAS OCCURRED FOR 1-2 HOURS. THE CUSTOMER HAS USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER USED THE SMARTGUARD/AUTO MODE OF THE INSULIN PUMP AT THE TIME OF REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-442AK, UNK_SENSOR AND MMT-1884L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101285 PUMP MMT-1884L MM780G BLE 3.0 MG/ML INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER, INSULIN SUSPEND QJS MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3674873H 000000763000819385

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other FRN-UNK_RESERVOIR-RSVR, MDS-UNK_SENSOR-SNSR| UNOMED SET