BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 24187911 · Received January 27, 2026

    Report

    Report Number
    2032227-2026-114549
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000544317
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF-TEST. THE PUMP PRIMED AND SEATED PROPERLY WHEN THE TEST RESERVOIR WAS DETECTED. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. THE PUMP WAS PROGRAMMED WITH MULTIPLE BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY AND SUMMARY HISTORY SCREENS. SUCCESSFULLY DOWNLOADED HISTORY FILES USING THUS SOFTWARE. HOWEVER, PUMP ERROR 81 WAS CONFIRMED ON (B)(6) 2026 19:08:36:000 PM AND PUMP ERROR 82 (MOTOR POWER TIMEOUT ALARMS). ON (B)(6) 2026 19:08:37:000 PM DUE TO MOISTURE DAMAGE ON ELECTRONICS ASSEMBLY, UNIT RECEIVED WITH DAMAGE SERIAL NUMBER LABEL. UNIT WAS NOT CONFIRMED FOR DRIVE/MOTOR ANOMALIES NOTED PUMP ERROR'S 81 AND 82 DUE TO MOISTURE DAMAGE. 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 EXPERIENCED BLEEDING AND CUSTOMER ALLEGED PUMP ERROR 81 (THE MOTOR PROCESSOR DID NOT ACK A COMMAND FROM DELIVERY MANAGER IN REASONABLE TIME. DATA IN ALARM CAN IDENTIFY WHICH COMMAND IT WAS) AND PUMP ERROR 82 (THE HRM TASK DID NOT GRANT MOTOR POWER IN REASONABLE TIME), CHANGE SENSOR ALERT AND CALIBRATION NOT ACCEPTED ERROR. THE EVENT INVOLVED PRODUCT MMT-1886. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS UNRESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE PUMP USE AND REVERT TO BACK UP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PRODUCT MMT-1886 WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68906 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3740143H 000000763000544317

    Patients

    Seq Age Sex Outcome Treatment
    1