BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 20671177 · Received November 13, 2024

    Report

    Report Number
    2032227-2024-267863
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 19, 2024
    Report Date
    January 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063926601
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. NO PUMP ERROR 53, PUMP ERROR 4, PUMP ERROR 82 ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. PUMP ERROR 82 WAS FOUND IN THE HISTORY FILE ON 10/19/2024 00:27:00.000. DURING SELF TEST, THE RED LED INDICATOR TURNED ON AND THE VIBRATOR MOTOR VIBRATED WITH BOTH FUNCTIONING PROPERLY WHICH INDICATES THE HARDWARE WORKED AS EXPECTED. PUMP ERROR 53 WAS PRESENT IN THE HISTORY DOWNLOAD ON 10/19/2024 00:27:08.000 (FILE NUMBER: 32/32143; LINE NUMBER: 265/399) DUE TO HARDWARE ERROR. PUMP ERROR 4 ALARM WAS FOUND IN THE HISTORY FILES ON 10/19/2024 00:27:08.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, SCRATCHED CASE, STAINED KEYPAD OVERLAY AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 82 ALARM WAS CONFIRMED IN THE PUMP HISTORY DUE TO A SOFTWARE ANOMALY. TRACE FILES WERE REVIEWED, AND THE DATA SHOWS THE MOTOR REQUESTED THAT THE POWER TURNED ON FROM THE MAIN MICROCONTROLLER AND THE MAIN MICROCONTROLLER DID NOT RESPOND AFTER THE 500MS THRESHOLD, THEREFORE GENERATING PUMP ERROR 82 WHICH IS EXPECTED. THIS WAS DUE TO A SOFTWARE RACE CONDITION WHERE MULTIPLE ACTIONS WERE TRYING TO BE COMPLETED AT ONE TIME. THIS SOFTWARE RACE CONDITION IS BEING STUDIED IN ESF 3562136 AND ESF 4669627.PUMP ERROR 53 WAS CONFIRMED DUE TO HARDWARE ERROR. PUMP ERROR 4 WAS CONFIRMED DUE TO A PUMP ERROR 53. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. 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 PUMP ERROR 4, PUMP ERROR 82 AND PUMP ERROR 53. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ABLE TO CLEAR THE ERROR AND PUMP PASSED DISPLACEMENT TEST. PUMP DID NOT PASS ADDITIONAL TESTING OR ERROR TABLE INDICATED THAT REPLACEMENT WAS REQUIRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE AND THE INSULIN PUMP. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658158 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3495692H 000076300063926601

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown