BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 17833716 · Received September 28, 2023

    Report

    Report Number
    2032227-2023-277148
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 3, 2023
    Report Date
    November 19, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 24 ALARM FOUND ON (B)(6) 2023.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 0.08740 INCHES.THE PUMP WAS MONITORED AND NO PUMP ERROR 24 ALARM NOTED.SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS.PUMP ERROR 24 ALARM (FILE NUMBER: 121 LINE NUMBER: 484) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 12:02:00.000, (B)(6) 2023 12:12:00.000(B)(6) 2023 15:27:00.000, (B)(6) 2023 15:37:00.000(B)(6) 2023 16:47:00.000, (B)(6) 2023 16:57:00.000(B)(6) 2023 17:50:00.000(B)(6) 2023 18:00:00.000(B)(6) 2023 22:01:00.000, (B)(6) 2023 22:11:00.000(B)(6) 2023 00:33:00.000, (B)(6) 2023 00:43:00.000(B)(6) 2023 02:47:00.000, (B)(6) 2023 02:57:00.000(B)(6) 2023 07:37:00.000(B)(6) 2023 08:10:00.000(B)(6) 2023 11:27:00.000, (B)(6) 2023 11:37:00.000(B)(6) 2023 12:46:01.000, (B)(6) 2023 12:56:01.000(B)(6) 2023 21:36:00.000, (B)(6) 2023 21:46:00.000PUMP ERROR 24 ALARM (FILE NUMBER: 121 LINE NUMBER: 484) WAS CONFIRMED, SUSPECTED ON HW. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 03-SEP-2023 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 02:00:00.000LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 02:19:00.000(B)(6) 2023 02:29:00.000THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (2) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING.POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 13:05:27.000, (B)(6) 2023 16:01:29.000(B)(6)2023 17:40:39.000 (B)(6) 2023 21:58:08.000(B)(6)2023 22:27:57.000, (B)(6)2023 02:26:05.000(B)(6)2023 05:48:54.000, (B)(6)2023 05:58:00.000(B)(6)2023 10:39:04.000, (B)(6)2023 11:44:00.000(B)(6)2023 15:46:53.000INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 12:08:13.000 TO (B)(6)2023 12:13:32.000(B)(6)2023 15:29:53.000, (B)(6) 2023 15:30:04.000, (B)(6)2023 15:30:06.000, (B)(6)2023 15:30:08.000(B)(6)2023 16:55:27.000(B)(6)2023 18:23:47.000, (B)(6)2023 18:24:30.000, (B)(6)/2023 18:24:32.000(B)(6)2023 22:02:25.000, (B)(6)2023 22:03:04.000, (B)(6)2023 22:03:06.000, (B)(6)2023 22:03:08.000(B)(6)2023 22:04:06.000, (B)(6)2023 22:04:08.000(B)(6)2023 00:37:26.000(B)(6)2023 03:52:39.000(B)(6)2023 10:22:08.000(B)(6)2023 11:32:33.000(B)(6)2023 15:11:18.000, (B)(6)2023 15:37:47.000, (B)(6)2023 15:46:13.000FAILED BATTERY ALERT/BATTERY FAILED ALARM(B)(6)2023 12:08:13.000 TO (B)(6)2023 12:13:31.000(B)(6)2023 15:30:03.000 , (B)(6)2023 15:30:05.000, (B)(6)2023 15:30:07.000(B)(6)2023 18:24:29.000, (B)(6)2023 18:24:31.000(B)(6)2023 22:03:03.000, (B)(6)2023 22:03:05.000, (B)(6)2023 22:03:07.000, (B)(6)2023 22:04:05.000(B)(6)2023 22:04:07.000(B)(6)2023 15:23:20.000 TO 09/03/2023 15:42:30.000(B)(6)2023 16:17:02.000 TO 09/05/2023 16:18:01.000POWER 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 EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATT ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER MAY HAVE USED A LOW POWER/DEPLETED 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT.PUMP ERROR 24 ALARM WAS CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2.MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A CRITICAL PUMP ERROR 24 WITH RECURRENCE. NO FURTHER DETAILS WERE GIVEN. TROUBLESHOOTING WAS PERFORMED AND FOUND IN THE HISTORY OF THE ALARM 3RD OCCURRENCE WITHIN 30 DAYS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982907 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG5UWMQ 000000763000317157

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown