BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21104240 · Received January 8, 2025

    Report

    Report Number
    2032227-2025-105142
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 28, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PUMP SUCCESSFULLY DOWNLOADED TRACES AND HISTORY FILE USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 63 ALARMS ON (B)(6) 2024 23:29:45.000, (B)(6) 2024 23:29:53.000, (B)(6) 2024 23:30:06.000, (B)(6) 2024 23:30:17.000 HARDWAREERRORALARM (63) FILE NUMBER: 2017, LINE NUMBER: 147 SW/HW: HW (POSSIBLE HW) GROUPING: TWI INTERFACE ON MAIN/MOTOR PROCESSOR. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE ELECTRONIC ASSEMBLY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING AND CRACKED CASE (BATTERY TUBE). CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 63 ALARMS. PUMP ERROR 63 ALARM, SUSPECTED ON HW. PUMP EXPOSED TO MOISTURE 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. 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), PUMP ERROR 63(HARDWARE LOW LEVEL FAILURES). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105906 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3115820H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male