BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20393637 · Received October 8, 2024

    Report

    Report Number
    2032227-2024-249772
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE SELF-TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING, AND P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. PUMP WAS CUT TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF NO PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. CONFIRMED PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON (B)(6) 2024 03:16:09.000 BOLUS, (B)(6) 2024 03:26:05.000 BOLUS, (B)(6) 2024 03:31:05.000 BOLUS,(B)(6) 202416:21:13.000 BOLUS AND (B)(6) 202400:31:07.000 BOLUS IN PUMP DOWNLOADED HISTORY DURING BOLUS. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, SCRATCHED CASE AND LABEL DAMAGE (STAINED). NO DELIVERY/OCCLUSION ALARM, UNEXPECTED INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. UNABLE TO VERIFY CUSTOMER'S HIGH BGS. COSMETIC DAMAGES WERE NOTED DURING VISUAL INSPECTION. 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

    (B)(4). 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 NO DELIVERY/OCCLUSION ALARM, OCCLUDED. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 200 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA WHICH DID NOT REQUIRE TREATMENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884, MMT-397A, MMT-332A. TROUBLESHOOTING WAS PERFORMED CUSTOMER REPORTED INSULIN FLOW BLOCKED ALARM. PUMP PASSED 5U FILL CANNULA TEST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248235 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 NG3501191H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female