BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NGP

    MDR report key: 24204060 · Received January 28, 2026

    Report

    Report Number
    2032227-2026-115706
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 12, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    (B)(6) 2026 19:19:25 LOW BGS/OVER DELIVERY T/S PER DOP114-980DOC VER BC. CUSTOMER REPORTED LOW BGS. CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED LOW BG EVENT. CUST DOES NOT BELIEVE THE PUMP IS OVER DELIVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85326 UNKNOWN NGP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED UNK_NGP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other RESERVOIR (FRN) / INFUSION SET (FPA).