BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 23288857 · Received October 15, 2025

    Report

    Report Number
    2032227-2025-284005
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 28, 2025
    Report Date
    January 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED, NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM AND FROZEN SCREEN NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. POWER LOSS ALARM WAS FOUND ON: 09/28/2025 14:39:20.000, 09/28/2025 14:39:28.000. 09/28/2025 19:10:21.000, 09/28/2025 19:10:29.000. INSERT BATTERY ALARM WAS FOUND ON: 09/28/2025 14:15:10.000, 09/28/2025 14:15:36.000. 09/28/2025 14:16:58.000, 09/28/2025 14:18:06.000. 09/28/2025 14:28:08.000, 09/28/2025 14:29:17.000. 09/28/2025 14:31:11.000, 09/28/2025 14:38:27.000. 09/28/2025 19:09:40.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 09/28/2025 14:01:09.000 TO 09/28/2025 14:38:13.000. PUMP ERROR 23 ALARM WAS FOUND ON: 09/28/2025 14:39:05.000. 09/28/2025 19:10:02.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. OLD POWER MANAGEMENT TOOL WAS USED AND THERE WAS NO POWER DATA AVAILABLE FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED DURING TESTING. PUMP WAS MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM/POWER LOSS ALARM NOTED. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 28-SEP-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 09/26/2025 18:03:00.000. SENSOR ERROR ALERT (801) WAS FOUND ON: 09/28/2025 19:09:01.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. PUMP ERROR 63 ALARM (LINE NUMBER: 187 FILE NUMBER: 2017) WAS FOUND ON: 09/28/2025 14:01:06.000. PUMP ERROR 4 ALARM WAS FOUND ON: 09/28/2025 14:01:06.000. PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (LINE NUMBER: 187 FILE NUMBER: 2017) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND FROZEN SCREEN WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (LINE NUMBER: 187 FILE NUMBER: 2017) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. 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

    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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 ALLEGED FOR BATTERY ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1886. TROUBLESHOOTING WAS PERFORMED FOR FROZEN SCREEN AND THE PUMP WOULD BE REPLACED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-1886 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646990 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG6C85VZZ 000000763000521554

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown