BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21301282 · Received February 4, 2025

    Report

    Report Number
    2032227-2025-120316
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 17, 2025
    Report Date
    May 19, 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
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE DISPLACEMENT AND SELF-TESTS. NO UNEXPECTED 53, 55 ALARMS NOTED DURING TESTING. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND PUMP ERROR 53 ALARMS FILE ON 12/22/2024 02:12:00.000, 01/18/2025 01:59:54.000, 01/18/2025 02:12:21.000, 01/19/2025 01:57:57.000. FILE NUMBER: 99 2001 2001, LINE NUMBER: 114 161 480 ESF#: 3764385 POSSIBLE HW ERROR. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY CONNECTOR, BATTERY TUBE, MOTOR, VIBRATOR DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), LABEL DAMAGE. PUMP PASSED ALL TEST REQUIRED, NO PUMP ERROR 55, 53 ALARMS NOTED DURING TESTING. HOWEVER, PUMP ERROR 53 ALARMS CONFIRMED IN THE PUMP HISTORY DUE TO HARDWARE ERROR ELECTRONIC DEFECTIVE. 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 RECEIVED THE FLASH CRC IS INCORRECTLY FOR FACTORY-STORED INFORMATION. (CRITICAL PUMP ERROR 55). THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 259 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH A MANUAL INJECTION/INSULIN PEN. THE EVENT INVOLVED PRODUCT(S) MMT-1880, MMT-332A, MMT-397A. THE PUMP CONTINUED TO ERROR AFTER CHANGING BOTH THE INFUSION SET AND RESERVOIR AND REATTEMPTING THE PRIME PROCESS WITH A NEW SET OF HIGH BGS/UNDER DELIVERY. THE CUSTOMER REPORTED HIGH BGS. THE CUSTOMER DOES NOT FEEL OKAY TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1880 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WOULD BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53259 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 NG3184647H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male