BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 22010837 · Received May 13, 2025

    Report

    Report Number
    2032227-2025-173760
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 14, 2025
    Report Date
    July 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300058619502
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    UPDATED SUMMARY: CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE WAS FLUCTUATING AND HE TREATED A HIGH BLOOD GLUCOSE WITH PUMP PER REGULATORY REPORT 2032227-2025-173409 AND THAT LED TO A LOW BLOOD GLUCOSE ON THE SAME DAY. HE WENT TO THE EMERGENCY ROOM FOR THE LOW OF 72MG/DL. THERE WAS NO MENTION OF USE OF EMERGENCY MEDICAL SERVICES. LOW WAS TREATED WITH GLUCOSE. CUSTOMER TOOK ZEPBOUND. PLEASE SEE REGULATORY REPORT 2032227-2025-173409 FOR THE HIGH BLOOD GLUCOSE DOCUMENTATION. CUSTOMER WILL DISCONTINUE THE PUMP AND RETURN IT UNDER REGULATORY REPORT 2032227-2025-173738. .

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND THE BLOOD GLUCOSE'S WERE FLUCTUATING. CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 72 MG/DL. CUSTOMER WAS TREATED WITH GLUCOSE AND EMERGENCY MEDICAL SERVICES. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-244A, MMT-1880L, MMT-7020MLA. TROUBLESHOOTING WAS PERFORMED FOR HYPOGLYCEMIA AND THE CUSTOMER ALLEGED INSULIN PUMP IN USE LEAD UP TO THE HOSPITALIZATION WAS NOT USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-244A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1880L. NO PRODUCT RETURN IS REQUIRED FOR MMT-7020MLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356829 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3832769H 000076300058619502

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention FRN-MMT-332A-RSVR, UNOMED SET,OZP-MMT-7020MLA-SNSR