BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 24449842 · Received February 25, 2026

    Report

    Report Number
    2032227-2026-134880
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 19, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF-TEST OR VERIFY PUMP ERROR 24 ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE), UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP SOFTWARE. HOWEVER ON ADAPT, CONFIRMED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED AND WAS TRIGGERED BY MULTIPLE PUMP ERROR 24 FATAL ALARM CONFIRMED IN PUMP DIAGNOSTIC TRACE FILE HISTORY ON EVENT DATE 02/19/2026 20:31:00.000 HOUR , 02/19/2026 20:21:00.000. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, AND FORCE SENSOR. SWAPPING OUT TEST BOARDS CONFIRMS CRITICAL PUMP ERROR (OPEN BOOK IMAGE) IS ISOLATED TO PCBA 2. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, LABEL DAMAGE AND PILLOWING KEYPAD OVERLAY.. UNABLE TO CONFIRM PUMP ERROR 24 DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE). CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DURING TESTING AND PUMP ERROR 24 IN TRACE HISTORY IS ISOLATED TO PCBA2 CONFIRMED. 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

    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. 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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. 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 PUMP ERROR 24(THIS ALARM IS GENERATED WHEN A POWER FAILURE IS DETECTED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. EXPLAIN THE PUMP PERFORMS SAFETY CHECKS AND AN ERROR WAS FOUND. THE PUMP DOES NOT SHOW ANY SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1886 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505636 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3167964H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown