BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24134019 · Received January 21, 2026

    Report

    Report Number
    2032227-2026-111785
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 2, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000630010
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR 24 ALARM. UNABLE TO VERIFY FROZEN SCREEN AND PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR 24 ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 2 DAYS FROM THE EVENT DATE OF 02-JAN-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 01/02/2026 17:31:41.000, 01/02/2026 18:48:37.000, 01/02/2026 18:53:28.000. PUMP ERROR 23 ALARM WAS FOUND ON: 01/02/2026 18:50:12.000. POWER LOSS ALARM WAS FOUND ON: 01/02/2026 18:50:42.000, 01/02/2026 18:50:50.000. 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING THE DETAILED TRACE FILE/DIAGNOSTIC TRACE FILE, PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED. THE BEHAVIOR WAS EXPECTED SINCE THE USER REMOVED AA BATTERY AND PRESSED BACK KEY FOR > 8 SEC - THIS DISCONNECTS BACKUP BATTERY AND PUMP LOOSES POWER. UNABLE TO TEST FOR PUMP ERROR 23 ALARM AND POWER LOSS ALARM DUE TO CRITICAL PUMP ERROR 24 ALARM. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE UNKNOWN. CRITICAL PUMP ERROR 24 ALARM (FILENUMBER 33 LINENUMBER 2188) WAS FOUND ON: 01/02/2026 17:29:00.000, 01/02/2026 17:39:00.000, 01/02/2026 18:48:00.000. CRITICAL PUMP ERROR 24 ALARM (FILENUMBER 33 LINENUMBER 2188) WAS CONFIRMED, 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. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.93 MV). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A STAINED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS AND A SCRATCHED CASE. UNABLE TO VERIFY FROZEN SCREEN AND PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR 24 ALARM. CRITICAL PUMP ERROR 24 ALARM (FILENUMBER 33 LINENUMBER 2188) WAS CONFIRMED, 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

    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 ALLEGED PUMP ERROR 24 (THIS ALARM IS GENERATED WHEN A POWER FAILURE IS DETECTED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT- 1812. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS UNRESOLVED ALSO PUMP SCREEN TURN OFF. NO HARM REQUIRING MEDICAL INTERVENTIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE PUMP USE AND REVERT TO BACK UP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PRODUCT MMT- 1812 WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202005 MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1812 NG3330624H 000000763000630010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown