BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 24196430 · Received January 27, 2026

    Report

    Report Number
    2032227-2026-114920
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 11, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063923501
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE DISPLACEMENT TEST, SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED, NO DELIVERY ALARMS NOTED DURING TESTING. THUS, SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. ALARMED NO DELIVERY SHOW IN THE TRACE/HISTORY FILES ON EVENT DATE (B)(6) 2026 23:37:49.000, (B)(6) 2026 23:39:11.000, (B)(6) 2026 23:48:02. DURING PRIME. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO COMPONENT OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR ASSEMBLY AND FORCE SENSOR. THE SC1 CAP LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. UNIT HAD SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY. IN CONCLUSION, PUMP PASSED ALL TESTING REQUIRED INSULIN FLOW BLOCKED/NO DELIVERY ALARMS NOT 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. 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 REPORTED HIGH BLOOD GLUCOSE (HYPERGLYCEMIA) AND AN INSULIN FLOW-BLOCKED ALARM. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE EVENT INVOLVED PRODUCTS MMT-1886. TROUBLESHOOTING WAS PERFORMED FOR THE INSULIN FLOW BLOCK, AND THE CUSTOMER CONFIRMED INSULIN DID NOT EXIT DURING 5U FILL CANNULA OR PUMP ALARMED. TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE, AND IT WAS UNKNOWN WHETHER THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT OR NOT. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USED THE AUTO MODE FEATURE AT THE TIME OF THE EVENT OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1886 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40538 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3469944H 000076300063923501

    Patients

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