BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21064972 · Received January 3, 2025

    Report

    Report Number
    2032227-2025-101406
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 14, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    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. 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

    PUMP PASSED THE SELF TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST DUE TO A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. PUMP ERROR 38 ALARM WAS FOUND ON: 12/14/2024 14:25:56.000, 12/14/2024 14:26:54.000 12/14/2024 14:28:24.000, 12/14/2024 14:32:03.000 12/14/2024 14:36:07.000, 12/14/2024 14:42:28.000 02/03/2025 07:40:30.000 02/03/2025 07:41:17.000 PUMP ERROR 42 ALARM WAS FOUND ON: 12/14/2024 13:47:26.000 12/14/2024 13:57:00.000 PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A JAMMED MOTOR GEAR BOX. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A TEST MOTOR WAS USED AND CONTINUED ON REWIND TEST. THE PUMP REWIND, LOAD RESERVOIR AND NO RESERVOIR DETECTED ALARMS PROPERLY. THE PUMP REWINDS SUCCESSFULLY. THE PUMP PASSED THE REWIND TEST. THE PUMP HAD A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST AND PUMP ERROR 42 ALARM (RECORDED IN THE FORMATTED HISTORY FILE) WERE CONFIRMED DUE TO A JAMMED MOTOR GEAR BOX. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 14-DEC-2024 IN THE FORMATTED HISTORY FILE. LOSTSENSOR1ALERT (780) WAS FOUND ON: 12/14/2024 15:52:00.000 12/14/2024 16:02:00.000 SENSORERRORALERT (801) WAS FOUND ON: 12/13/2024 00:05:33.000 12/13/2024 00:15:00.000 12/13/2024 07:35:33.000 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 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. INSERT BATTERY ALARM WAS FOUND ON: 12/14/2024 17:13:18.000 12/14/2024 17:23:00.000 12/14/2024 17:24:46.000 12/14/2024 17:24:52.000 POWER LOSS ALARM WAS FOUND ON: 12/14/2024 17:27:48.000 12/14/2024 17:27:56.000 PUMP ERROR 23 ALARM WAS FOUND ON: 12/14/2024 17:24:04.000 12/14/2024 17:26:26.000 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. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. UNABLE TO PERFORM THE REQUIRED TESTING DUE TO A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. THE PUMP HAD A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST AND PUMP ERROR 42 ALARM (RECORDED IN THE FORMATTED HISTORY FILE) WERE CONFIRMED DUE TO A JAMMED MOTOR GEAR BOX. 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 PUMP ERROR 38(NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ERROR BUT WAS UNABLE TO COMPLETE THE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116748 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 NG3796462H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female