BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 20949283 · Received December 17, 2024

    Report

    Report Number
    2032227-2024-287581
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 24, 2024
    Report Date
    January 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0874 INCHES. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM NOTED. THE PUMP WAS MONITORED DURING TESTING. NO BLANK DISPLAY NOTED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO DAMAGE NOTED ON THE BATTERY CAP. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 24-NOV-2024 IN THE PUMP HISTORY FILE. 11/18/2024 23:39:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS. 11/24/2024 23:28:09.000 BATTERYREMOVED 11/24/2024 23:28:09.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:28:13.000 BATTERYINSERTED 11/24/2024 23:28:13.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) 11/24/2024 23:28:16.000 BATTERYREMOVED 11/24/2024 23:28:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:28:20.000 BATTERYINSERTED 11/24/2024 23:28:20.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) 11/24/2024 23:28:29.000 BATTERYREMOVED 11/24/2024 23:28:29.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:28:36.000 BATTERYINSERTED 11/24/2024 23:28:36.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) 11/24/2024 23:28:36.000 BATTERYREMOVED 11/24/2024 23:28:36.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:28:41.000 BATTERYINSERTED 11/24/2024 23:28:41.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) 11/24/2024 23:28:52.000 BATTERYREMOVED 11/24/2024 23:28:52.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:28:57.000 BATTERYINSERTED 11/24/2024 23:28:57.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) 11/24/2024 23:33:01.000 BATTERYREMOVED 11/24/2024 23:33:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:33:21.000 BATTERYINSERTED 11/24/2024 23:34:04.000 BATTERYREMOVED 11/24/2024 23:34:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/24/2024 23:34:08.000 BATTERYINSERTED THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO DELIVERY (7) ALARM - NOT CONFIRMED. FAILED BATT TEST (58) - NOT CONFIRMED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA1, PCBA2 AND MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. THE PUMP PASSED THE FUNCTIONAL TESTING. FAILED BATT TEST NOT CONFIRMED. BLANK DISPLAY NOT CONFIRMED. BATTERY CAP CONTACT MISSING/DAMAGED NOT CONFIRMED. HOWEVER, MOISTURE DAMAGE WAS FOUND DURING VISUAL INSPECTION ON THE ELECTRONIC ASSEMBLY AND MOTOR. 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 FAILED BATT TEST, BLANK DISPLAY, BATTERY CAP CONTACT MISSING/DAMAGED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715KR. BATTERY FAILED ALARM CUSTOMER REPORTED RECEIVING BATTERY FAILED ALARM. CUSTOMER REPORTED THAT BATTERY CAP CONTACTS ARE DAMAGED. BATTERY CAP DAMAGED/LOST OR REQUESTING SPARE CUSTOMER REQUESTED SPARE BATTERY CAP. DISPLAY FLASHING/WHITE/BLANK/FROZEN/PARTIAL CUSTOMER REPORTED A BLANK DISPLAY. BATTERY CAP CONTACTS AND BATTERY COMPARTMENT AND/OR SPRINGS ARE NOT DAMAGED. DISPLAY DID NOT RETURN AFTER INSERTING A NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1715KR WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456197 630G INSULIN PUMP MMT-1715KR 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG4YBY7

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female