BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 21272209 · Received January 30, 2025

    Report

    Report Number
    2032227-2025-118441
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 14, 2025
    Report Date
    March 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08745 INCHES. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE PUMP SUCCESSFULLY DELIVERED A 10 UNITS BOLUS (DISPLACEMENT TEST) AND A 25 UNITS BOLUS (DAT). ALL BOLUSES WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNEXPECTED FLASHING MEDTRONIC LOGO NOTED. 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. INSERT BATTERY ALARM WAS FOUND ON: 01/14/2025 18:48:49.000 TO 01/14/2025 18:57:18.000; 01/14/2025 19:00:21.000 TO 01/14/2025 19:24:06.000; LOW BATTERY ALERT WAS FOUND ON: 01/14/2025 08:43:00.000; FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 01/14/2025 18:49:32.000 TO 01/14/2025 18:59:57.000; 01/14/2025 19:00:05.000 TO 01/14/2025 19:23:04.000; REPLACE BATTERY ALERT WAS FOUND ON: 01/14/2025 18:14:00.000; 01/14/2025 18:14:00.000; PUMP ERROR 68 ALARM WAS FOUND ON: 01/14/2025 19:23:58.000; 01/14/2025 19:24:18.000; PUMP ERROR 49 ALARM WAS FOUND ON: 01/14/2025 19:23:59.000; 01/14/2025 19:24:19.000; 01/14/2025 19:25:36.000; PUMP ERROR 23 ALARM WAS FOUND ON: 01/14/2025 19:25:57.000; POWER LOSS ALARM WAS FOUND ON: 01/14/2025 19:26:11.000; 01/14/2025 19:26:22.000; INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND REPLACE BATTERY ALERT WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A LOW/NO POWER BATTERY. UPON CHECKING THE DETAILED TRACE FILE/DIAGNOSTIC TRACE FILE, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM/POWER LOSS ALARM WERE EXPECTED. THE BEHAVIOR WAS EXPECTED SINCE THE USER REMOVED AA BATTERY AND PRESSED BACK KEY FOR > 8 SEC - THIS DISCONNECTS BACKUP BATTERY AND PUMP LOOSES POWER. NO UNEXPECTED LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM/POWER LOSS ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE OF 14-JAN-2025 IN THE FORMATTED HISTORY FILE. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS FOUND ON: 01/14/2025 19:03:51.000; 01/14/2025 19:04:38.000; 01/14/2025 19:05:01.000; 01/14/2025 19:06:38.000; 01/14/2025 19:07:39.000; 01/14/2025 19:08:58.000; 01/14/2025 19:11:46.000; PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (21.98 MV). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FLASHING MEDTRONIC LOGO AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. 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 FLASHING MEDTRONIC LOGO, FAILED BATTERY TEST. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT BATTERY CAP CONTACTS AND BATTERY COMPARTMENT WERE NOT DAMAGED OR CORRODED. CUSTOMER RECEIVED ANOTHER BATTERY FAILED ALARM AFTER INSERTING A NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1715K WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621388 630G INSULIN PUMP MMT-1715K 630G BLACK MG AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K NG3259323H 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female