BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 19275919 · Received May 9, 2024

    Report

    Report Number
    2032227-2024-165852
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 21, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2024 22:27:00.000 AND (B)(6) 2024 22:37:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE VIBRATOR ASSEMBLY NOTED. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL THE MOISTURE DAMAGE AREAS AND REINSTALLED THE ORIGINAL ELECTRONICS, CASE, INTERNAL BATTERY AND MOTOR. THE CRITICAL PUMP ERROR OCCURRED DURING TESTING. IN CONCLUSION, CRITICAL PUMP ERROR (OPEN BOOK) AND PUMP ERROR 35 ALARM FOUND IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-APR-2024 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 17:26:00.000, (B)(6) 2024 17:36:00.000. LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 17:52:00.000, (B)(6) 2024 18:02:00.000. UNABLE TO TEST FOR LOST SENSOR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT WAS UNKNOWN. PUMP ERROR 130 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 22:45:20.000, (B)(6) 2024 22:45:25.000. PUMP ERROR 130 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE MOTOR ASSEMBLY NOTED. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 22:45:40.000. 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. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT; HOWEVER, A CRACKED RETAINER AND A RETAINER KNIT LINE DAMAGE WERE NOTED 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. RETAINER RING DAMAGE (A CRACKED RETAINER AND A RETAINER KNIT LINE DAMAGE) WAS CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. ALSO, PUMP ERROR 130 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE MOTOR ASSEMBLY NOTED. 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. 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 CRITICAL PUMP ERROR (OPEN BOOK IMAGE) AND PUMP ERROR 35 (A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED OR RETURN AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469702 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 NG3448546H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female