BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGP 3ML MMOL/L PUMP WITH PLGM

    MDR report key: 23506526 · Received November 9, 2025

    Report

    Report Number
    2032227-2025-297245
    Event Type
    Malfunction
    Date Received
    November 9, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 8, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. BURNSIDE, MERCEDES J. "CONTINUOUS SUBCUTANEOUS OCTREOTIDE INFUSION IN CONGENITAL HYPERINSULINISM: PRACTICAL APPLICATION AND INSIGHTS IN INFANCY AND EARLY CHILDHOOD". JOURNAL OF DIABETES & METABOLIC DISORDERS, VOLUME 24, ARTICLE NUMBER 222, 2025, HTTPS://DOI.ORG/10.1007/S40200-025-01709-2. 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 HYPOGLYCEMIA AND DISCOMFORT AT INSERTION SITE. THE CUSTOMER ALSO REPORTED PUMP MALFUNCTION. THE CUSTOMER WAS HOSPITALIZED TO TREAT HYPOGLYCEMIA. THE EVENT INVOLVED PRODUCT(S) MMT-1711, MMT-399, MMT-332. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1711. NO PRODUCT RETURN IS REQUIRED FOR MMT-399. NO PRODUCT RETURN IS REQUIRED FOR MMT-332.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501690 NGP 3ML MMOL/L PUMP WITH PLGM PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown