BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 21133613 · Received January 12, 2025

    Report

    Report Number
    2032227-2025-107635
    Event Type
    Malfunction
    Date Received
    January 12, 2025
    Date of Event
    December 20, 2024
    Report Date
    May 21, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063926601
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED 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, DISPLACEMENT TEST AND DAT WITHIN SPECIFICATION AT .08750 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO ABSENCE OF NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING THE TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONING PROPERLY. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE SS EVENT DATE OF (B)(6) 2024 AND CUSTOMER'S EVENT DATE OF (B)(6) 2024, THERE WERE NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. ON THE SS EVENT DATE OF (B)(6) 2024 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 149750 (14.975 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 75750 (7.575 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 225500 (22.55 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. ON THE CUSTOMER'S EVENT DATE OF (B)(6) 2024 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 375250 (37.525 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 810500 (81.05 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 1185750 (118.575 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE SS EVENT DATE OF (B)(6) 2024 AND CUSTOMER'S EVENT DATE OF (B)(6) 2024, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 12:44:56.000; (B)(6) 2024 15:08:18.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2024 12:45:13.000; (B)(6) 2024 15:08:32.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 12:45:26.000; (B)(6) 2024 12:45:34.000; (B)(6) 2024 15:08:43.000; (B)(6) 2024 15:08:51.000. 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/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. NO UNEXPECTED PUMP ERROR 23 ALARM/POWER LOSS ALARM NOTED DURING TESTING. 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 (23.44MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP. THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER ALLEGED FOR ABSENCE OF NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM (PUMP DID NOT ALARM DURING HP TEST) WAS NOT CONFIRMED. 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 HYPERGLYCEMIA WITH DEVICE TEST FAILED AS PUMP FAILED HIGH PRESSURE TEST. THE CUSTOMER REPORTED HYPERGLYCEMIA WHICH WAS TREATED WITH INTRAVENOUS INSULIN INFUSION AND EMERGENCY MEDICAL SERVICES (EMS)/AMBULANCE/EMERGENCY ROOM (ER) VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED AND AND THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. THE HIGH PRESSURE TEST DID NOT PASS TWICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WOULD DISCONTINUE THE USE OF THE DEVICE. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506065 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3680436H 000076300063926601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown