BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20166434 · Received September 8, 2024

    Report

    Report Number
    2032227-2024-233827
    Event Type
    Injury
    Date Received
    September 8, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED PROPERLY DURING TESTING. PUMP POWERED UP PROPERLY UPON BATTERY INSTALLATION. UNIT SUCCESSFULLY PASSED SELF-TEST AND DISPLACEMENT TEST. UNIT WAS SUCCESSFULLY DOWNLOADED TO THUMP. VERIFIED PUMP ERROR 53 ALARMS (FILE NUMBER 32107 LINE NUMBER 458) IN THE ADAPT TOOL FAULT MAIN ERROR LOG ON 0707/29/2024 11:18:47.000. PER SOFTWARE ENGINEER LOG IT WAS DETERMINED THAT PUMP ERROR 53 WAS WAS TRIGGERED ON MOTOR MCU DUE TO QUEUE OVERFULL WHEN MOTOR APP SENT MESSAGE TO MOTOR DELIVERY MANAGER. ISOLATE TO ELECTRONIC ASSEMBLY. AS A RESULT, PUMP ERROR 3 AND PUMP ERROR 19 WERE TRIGGERED ON 07/29/2024 11:18:47.000. UNIT WAS CUT OPEN FOR VISUAL INSPECTION OF INTERNAL COMPONENTS. NO MOISTURE DAMAGE FOUND TO THE MOTOR ASSEMBLY, PCB1 BOARD, AND PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY AND SCRATCHED CASE. PUMP ERROR 53 ALARMS CONFIRMED IN PUMP DOWNLOAD HISTORY. ISOLATE TO ELECTRONIC ASSEMBLY. PUMP ERROR 3 AND PUMP ERROR 19 WERE FOUND IN PUMP DOWNLOAD HISTORY. COSMETIC DAMAGE CONFIRMED WHEN STAINED KEYPAD OVERLAY. 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 EXPERIENCED HARM REPORTED WITH NO REPORTED ALLEGATION OF A DEVICE MALFUNCTION, HARM REPORTED WITH NO REPORTED ALLEGATION OF A DEVICE MALFUNCTION, PUMP ERROR 53, PUMP ERROR 19, AND PUMP ERROR 3. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 50 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH GLUCOSE/CARB INTAKE. THE CUSTOMER STATED THAT THE CAUSE OF THE HYPOGLYCEMIA EPISODE WAS UNKNOWN, AND THE TREATMENT FOR HYPERGLYCEMIA WAS DONE WITH AN INSULIN PUMP. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-332A, MMT-394A, AND MMT-1884. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED LOW BLOOD GLUCOSE. THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER DOES NOT BELIEVE THE PUMP WAS OVER-DELIVERING. THE CUSTOMER REPORTED RECEIVING A PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR AND THE FILL CANNULA DELIVERY TEST WAS SUCCESSFUL. THE ERROR TABLE DID NOT INDICATE THAT THE PUMP SHOULD BE REPLACED AND THE PUMP PASSED A SELF-TEST. THE CUSTOMER WAS NOT USING THE QUICK BOLUS SPEED FEATURE ON AN IMPACTED PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-394A. 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
    1510156 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 NG3714661H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other FRN-MMT-332A-RSVR, UNOMED INF SET.| OZP-MMT-7040A-SNSR.