BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 20470741 · Received October 17, 2024

    Report

    Report Number
    2032227-2024-256063
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 29, 2024
    Report Date
    March 21, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000630003
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED AND NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. THERE IS NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS FOUND ON: 09/29/2024 06:03:39.000. REPLACE BATTERY ALERT WAS FOUND ON: 09/28/2024 17:00:00.000, 09/29/2024 11:00:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: 09/28/2024 17:31:00.000, 09/28/2024 17:41:00.000, 09/29/2024 11:31:00.000, 09/29/2024 11:41:00.000. POWER LOSS ALARM WAS FOUND ON: 09/28/2024 17:43:00.000, 09/28/2024 17:43:07.000, 09/29/2024 11:42:18.000, 09/29/2024 11:42:25.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE UNEXPECTED. THE CUSTOMER IS USING A GOOD BATTERY. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR¿ASSEMBLY NOTED. UNEXPECTED REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE OF 29-SEP-2024 IN THE FORMATTED HISTORY FILE. PUMP ERROR 53 ALARM (LINENUMBER 3201 FILENUMBER 26) WAS FOUND ON: 09/27/2024 22:23:52.000. PUMP ERROR 68 ALARM WAS FOUND ON: 09/27/2024 22:22:03.000, 09/27/2024 22:22:47.000, 09/27/2024 22:23:07.000, PUMP ERROR 49 ALARM WAS FOUND ON: 09/27/2024 22:22:03.000, 09/27/2024 22:22:25.000, 09/27/2024 22:22:47.000, 09/27/2024 22:23:07.000, 09/27/2024 22:23:29.000. PUMP ERROR 23 ALARM WAS FOUND ON: 09/27/2024 22:23:54.000, 09/28/2024 17:42:03.000, 09/29/2024 11:42:04.000. AS PER R&D ENGINEER: (B)(6), PUMP ERROR 53 ALARM (LINENUMBER 3201 FILENUMBER 26), PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE CONFIRMED, SUSPECTED ON HW. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A KEYPAD OVERLAY PEELING, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. HOWEVER, PUMP ERROR 53 ALARM (LINENUMBER 3201 FILENUMBER 26), PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM, UNEXPECTED REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. 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. 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. 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 EXPERIENCED FAILED BATTERY TEST. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1811. CUSTOMER CALLED BACK AFTER RECEIVING A REPLACEMENT BATTERY CAP. CUSTOMER CONTINUED TO EXPERIENCE BATTERY FAILED ALARMS AFTER INSERTING A NEW BATTERY WITH THE NEW BATTERY CAP. ADVISED CUSTOMER THAT PUMP WILL BE REPLACED. OUTCOME INDICATED: REPORTED ISSUE RESOLVED, NO ESCALATION REQUIRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. MMT-1811 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249968 MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MMOL/L PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1811 HG6ED42ZZ 000000763000630003

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown