BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 20893763 · Received December 10, 2024

    Report

    Report Number
    2032227-2024-282916
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000367060
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TESTING, THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF-TEST. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PEELING DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND STAINED KEYPAD OVERLAY. 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 15-NOV-2024 IN THE PUMP HISTORY FILE. 11/13/2024 03:06:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 11/13/2024 03:48:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = CHANGE BATTERY FAULT (73) 11/13/2024 03:50:30.000 BATTERYREMOVED 11/13/2024 03:50:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/13/2024 03:54:33.000 BATTERYINSERTED 11/14/2024 02:01:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 11/14/2024 02:50:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = CHANGE BATTERY FAULT (73) 11/14/2024 03:00:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = CHANGE BATTERY FAULT (73) 11/14/2024 03:03:19.000 BATTERYREMOVED 11/14/2024 03:03:19.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/14/2024 03:03:48.000 BATTERYINSERTED 11/15/2024 00:24:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 11/15/2024 00:25:07.000 BATTERYREMOVED 11/15/2024 00:25:07.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/15/2024 00:25:27.000 BATTERYINSERTED 11/15/2024 22:31:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 11/15/2024 22:32:42.000 BATTERYREMOVED 11/15/2024 22:32:42.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/15/2024 22:33:23.000 BATTERYINSERTED IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 26.0 RECEIVED THE LOWBATTERYALERT (104) ON 2024-11-14 02:01:00 FASTER THAN EXPECTED AT 0.92 DAYS. BATTERY CYCLE 25.0 RECEIVED THE LOWBATTERYALERT (104) ON 2024-11-13 03:06:00 FASTER THAN EXPECTED AT 4.53 DAYS. BATTERY CYCLE 24.0 RECEIVED THE LOWBATTERYALERT (104) ON 2024-10-25 08:12:00 AFTER MORE THAN 7 DAYS AT 24.4 DAYS. CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. LOW BATTERY ALERT (104) - CONFIRMED. CHANGE BATTERY FAULT (73) - 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. UNEXPECTED BATTERY POWER LOSS CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. CHARGE/BATTERY ANOMALY CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. NO CURRENT CODE/CATEGORY (LOW BATTERY ALERT (104)) CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. REPLACE BATTERY NOW ALARM/CHANGE BATTERY FAULT (73) CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. 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. 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 UNEXPECTED BATTERY POWER LOSS, CHARGE/BATTERY LASTS LESS THAN EXPECTED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715KR. CUSTOMER REPORTED RECEIVING REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM. THIS WAS THE SECOND OCCURRENCE OF RECEIVING ALARM IN LESS THAN 8 HOURS AFTER LOW BATTERY WARNING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1715KR WAS REQUESTED AND CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633188 630G INSULIN PUMP MMT-1715KR 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG5UX72 000000763000367060

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male