BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20223824 · Received September 16, 2024

    Report

    Report Number
    2032227-2024-238675
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 25, 2024
    Report Date
    October 22, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 AT 0.08740 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND ON: (B)(6) 2024 09:12:23.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 10:44:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 10:54:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 11:49:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 11:54:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 11:59:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 12:04:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 12:38:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 13:03:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 13:04:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 13:09:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 13:14:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 13:24:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 13:34:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2024 13:44:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 14:04:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 14:14:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 14:24:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 14:29:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2024 14:34:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 08/25/2024 14:39:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 25-AUG-2024 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 12:40:57.000. (B)(6) 2024 14:40:51.000. (B)(6) 2024 14:43:08.000. (B)(6) 2024 14:53:00.000. (B)(6) 2024 15:02:18.000. (B)(6) 2024 15:03:10.000. 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. SENSORERRORALERT (801) WAS FOUND ON: (B)(6) 2024 15:54:03.000. (B)(6) 2024 16:04:00.000. SGCALIBRATIONERROR (776) WAS FOUND ON: (B)(6) 2024 17:40:21.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL 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 WARMUP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR ERROR ALERT, SG CALIBRATION ERROR OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, 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 NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 REPORTED AN INSULIN FLOW BLOCKED ALARM. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-399A, MMT-1884. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-332A WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-399A. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112552 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 HG5JTTHZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female