BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 23368400 · Received October 23, 2025

    Report

    Report Number
    2032227-2025-289575
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 3, 2025
    Report Date
    March 17, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE ACTIVE CURRENT TEST AND SLEEP CURRENT TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS OR ALERTS NOTED DURING TESTING, HOWEVER, LOW BATTERY ALERTED ON 10/03/2025 13:32:01, 09/29/2025 10:27:00 AND 09/24/2025 07:23:00 AND FAILED BATTERY TEST ALERTED ON 10/03/2025 18:28:33 AND 10/03/2025 18:28:08 WERE FOUND IN THE HISTORY FILES OR TRACES. BATTERY CYCLE 8.0 RECEIVED THE LOW BATTERY ALERT (104) ON 10/03/2025 13:32:01 FASTER THAN EXPECTED AT 3.73 DAYS. BATTERY CYCLE 7.0 RECEIVED THE LOW BATTERY ALERT (104) ON 09/29/2025 10:27:00 FASTER THAN EXPECTED AT 4.73 DAYS. BATTERY CYCLE 6.0 RECEIVED THE LOW BATTERY ALERT (104) ON 09/24/2025 07:23:00 FASTER THAN EXPECTED AT 3.38 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE (MINOR). CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. UNEXPECTED BATTERY POWER LOSS AND CHARGE/BATTERY LASTS LESS THAN EXPECTED WERE CONFIRMED; PROBLEM SUSPECTING HARDWARE ISSUE. 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

    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. 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. 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 FREQUENT BATTERY DEPLETION, WITH BATTERIES LASTING ONLY AROUND THREE DAYS AND REQUIRING SEVEN REPLACEMENTS, AS WELL AS REPEATED LOW PUMP BATTERY, AND REPLACE BATTERY NOW ALARMS WITHIN EIGHT HOURS OF A LOW BATTERY WARNING. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1886. TROUBLESHOOTING WAS PERFORMED, INCLUDING REVIEWING ALARM HISTORY, CONFIRMING BATTERY AND CAP STATUS, AND ADVISING THE CUSTOMER THAT THE PUMP WILL BE REPLACED; THE CUSTOMER WAS INSTRUCTED THAT THEY COULD CONTINUE USING THE PUMP WITH A NEW BATTERY UNTIL THE REPLACEMENT ARRIVES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1886 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699076 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3915406H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown