BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 23131567 · Received September 24, 2025

    Report

    Report Number
    2032227-2025-267790
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 24, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    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. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0869 INCHES. THE FAULT LED TEST, VIBRATION TEST AND TONE TEST PASSED ON SELF TEST. HOWEVER, THE PUMP FAILED THE SCREEN TEST (HAD MISSING SEGMENTS) ON SELF TEST. NO CRACKED DISPLAY WINDOW NOTED. THE PUMP WAS RECEIVED WITH CRACKED CASE AT THE BATTERY TUBE SIDE. NO CRACKED BATTERY TUBE THREADS NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, STAINED SERIAL NUMBER LABEL, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND STAINED KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. ON RELATED CASE: (B)(4) (SVN: (B)(6), ON THE EVENT DATE OF 16-MAY-2025 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 90000 (9 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 436000 (43.6 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 526000 (52.6 U). ON RELATED CASE: (B)(4) (SVN: (B)(6), PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 16-MAY-2025 IN THE PUMP HISTORY FILE AND FOUND 2 LOST SENSOR ALERTS ON (B)(6) 2025 AND 1 LOST SENSOR ALERT ON (B)(6) 2025. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THERE WAS NO CRACKED OR BLEEDING LCD GLASS NOTED. HOWEVER, MISSING SEGMENTS WAS ISOLATED TO THE PCBA1/LCD GLASS. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.4 MV). UNABLE TO COMPLETE THE FUNCTIONAL TESTING, THE PUMP FAILED THE SELF TEST (THE SCREEN TEST HAD MISSING SEGMENTS). HOWEVER, THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT. THE FAULT LED TEST, VIBRATION TEST AND TONE TEST PASSED ON SELF TEST. UNABLE TO CONFIRM ALLEGED HIGH BGS/DKA. DISPLAY ANOMALY-MISSING SEGMENTS/PARTIAL DISPLAY CONFIRMED (ISOLATED TO THE PCBA1/LCD GLASS). DAMAGE- CRACKED DISPLAY WINDOW NOT CONFIRMED AT THE FRONT OF THE PUMP. DAMAGE- CRACKED CASE BATTERY TUBE CONFIRMED AT THE BACK OF THE PUMP. 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 THE BATTERY COMPARTMENT OF THE INSULIN PUMP BEING DAMAGED AND THE DISPLAY WINDOW OF THE PUMP BEING CRACKED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1886 WAS REQUESTED AND THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850836 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown