BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 19413104 · Received May 29, 2024

    Report

    Report Number
    2032227-2024-178536
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 22, 2024
    Report Date
    September 16, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST. THE PUMP WAS SUCCESSFULLY DOWNLOADED USING THUMP. NO PUMP ERROR 53 ALARM OCCURRED DURING TESTING. A REVIEW OF THE PUMP HISTORY FILE SHOWS THE FOLLOWING ERRORS WITH DETAILED ANALYSIS LISTED BELOW: PUMP ERROR 53 (LINE NUMBER 1594 FILE NUMBER 311) ALARM (B)(6) 2024 (10:55). PUMP ERROR 4 (LINE NUMBER 2690 FILE NUMBER 32122) ALARM (B)(6) 2024 (10:55). PUMP ERROR 53 (LINE NUMBER 9 FILE NUMBER 6400) ALARM (B)(6) 2024 (09:26). PUMP ERROR 53 (LINE NUMBER 32772 FILE NUMBER 32764) ALARM (B)(6) 2024 (00:54). PUMP ERROR 53 (LINE NUMBER 671 FILE NUMBER 172) ALARM (B)(6) 2024 (07:00). PUMP ERROR 53 (LINE NUMBER 1103 FILE NUMBER 1421) ALARM (B)(6) 2024 (07:08). PUMP ERROR 53 (LINE NUMBER 1594 FILE NUMBER 311) ALARM (B)(6) 2024 (12:36). PUMP ERROR 53 (FILE/LINE=311/1594) WAS CAUSED BY SOFTWARE ASSERT TRIGGERED IN THE UI_THINGGETTEXTFONT () FUNCTION BY INVALID POINTER - SUSPECTING THE HW (MEMORY CORRUPTION) PUMP ERROR 53 (FILE NUMBER 172 LINE NUMBER 671) PUMP ERROR 53 WAS TRIGGERED WHEN TRYING TO ALLOCATE MEMORY (NOT ENOUGH FREE MEMORY IN THE PEG POOL) IN THE SCREEN CREATION FUNCTION - SUSPECTING THE HW THE OTHER SW ERRORS WERE GENERATED DUE TO EXCEPTION ON MAIN MCU - SUSPECTING THE HW (BUM) PUMP ERROR 4 WAS THE CONSEQUENCE OF PE53 AND WAS EXPECTED. PUMP ERROR 58 (BATTERY FAILED) WAS ALSO EXPECTED SINCE THE USER ATTEMPTED TO USE EITHER DEPLETED AA BATTERY OR INCOMPATIBLE AA BATTERY. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO EVIDENCE OF DAMAGE OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2) AND MOTOR ASSEMBLY. A SC1 CAP LOCKS INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING A PHYSICAL INSPECTION: SCRATCHED CASE. PUMP ERROR 53 AND PUMP ERROR 4 ALARMS ARE CONFIRMED, FAULTS ARE ISOLATED TO THE HARDWARE. BATTERY FAILED ALARM IS NOT CONFIRMED SINCE THE USER ATTEMPTED TO USE EITHER DEPLETED AA BATTERY OR INCOMPATIBLE AA BATTERY. 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 OUTSIDE 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. 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 FAILED BATT TEST, PUMP ERROR 53. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED AND OUTCOME WAS PUMP REPLACEMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585434 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 NG3696791H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown