BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 17223251 · Received June 29, 2023

    Report

    Report Number
    2032227-2023-227549
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 10, 2023
    Report Date
    November 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317089
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED DISPLACEMENT TEST AND SELF TEST. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, MISSING 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, MISSING SERIAL NUMBER LABEL, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, AND CORRODED BATTERY TUBE. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO/VIBRATE/ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. NO PUMP ERROR 63 NOTED DURING TESTING. HOWEVER, MULTIPLE PUMP ERROR 63 (VARIABLE 15, FILE NUMBER: 2005, LINE NUMBER: 9926) WERE FOUND IN THE PUMP HISTORY FILE ON (B)(6) 2023 DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. PLEASE BELOW FOR THE DATE AND TIMES LISTED IN THE PUMP HISTORY FILE. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 10-JUN-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 18:55:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 18:55:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) (B)(6) 2023 18:55:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58) (B)(6) 2023 18:56:20.000 ALARMALERTNOTIFICATION FAULTNUMBER = SOFTWARE ERROR (53) FILE NUMBER: 2005 LINE NUMBER: 5632 (B)(6) 2023 18:56:23.000 BATTERYREMOVED (B)(6) 2023 18:56:23.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:56:40.000 BATTERYINSERTED (B)(6) 2023 18:56:47.000 BATTERYREMOVED (B)(6) 2023 18:56:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:56:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = SOFTWARE ERROR (53) FILE NUMBER: 2005 LINE NUMBER: 5632 (B)(6) 2023 18:56:47.000 BATTERYREMOVED (B)(6) 2023 18:56:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:57:02.000 BATTERYREMOVED (B)(6) 2023 18:57:10.000 BATTERYINSERTED (B)(6) 2023 18:57:16.000 BATTERYREMOVED (B)(6) 2023 18:57:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:57:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = SOFTWARE ERROR (53) FILE NUMBER: 2005 LINE NUMBER: 5632 (B)(6) 2023 18:57:16.000 BATTERYREMOVED (B)(6) 2023 18:57:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 18:57:23.000 BATTERYINSERTED (B)(6) 2023 18:57:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = SOFTWARE ERROR (53) FILE NUMBER: 2005 LINE NUMBER: 5632 (B)(6) 2023 19:08:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 19:19:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 19:30:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 19:40:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 20:09:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 20:19:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) SIREN (B)(6) 2023 20:20:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 20:30:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) SIREN (B)(6) 2023 20:20:59.000 BATTERYREMOVED (B)(6) 2023 20:20:59.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 20:21:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 20:21:24.000 BATTERYREMOVED (B)(6) 2023 20:21:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 20:31:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) SIREN (B)(6) 2023 20:32:02.000 ALARMALERTNOTIFICATION FAULTNUMBER = HARDWARE ERROR ALARM (63) (VARIABLE 15) FILE NUMBER: 2005 LINE NUMBER: 9926 (B)(6) 2023 20:32:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) - RESET (B)(6) 2023 20:32:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) (B)(6) 2023 20:37:15.000 BATTERYREMOVED (B)(6) 2023 20:37:15.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 20:47:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 20:48:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) - RESET (B)(6) 2023 20:48:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) (B)(6) 2023 20:48:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = TRACE CHECK ERROR (68) (B)(6) 2023 20:48:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6)(B)(6) 2023 20:48:37.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6) 2023 20:48:52.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) V2023 20:52:16.000 BATTERYREMOVED (B)(6) 2023 20:52:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 20:52:26.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) 2023 20:53:21.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) (B)(6) 2023 20:53:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT(6) HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 53 (B)(6) 2023 18:56:20.000, ON (B)(6) 2023 18:56:47.000, ON (B)(6) 2023 18:57:16.000 AND ON (B)(6) 2023 18:57:30.000 DUE TO SOFTWARE ERROR (LINENUMBER = 5632, FILENUMBER = 2005). THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILED BATTERY TEST ALARM WAS DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO PUMP RESET. PUMP ERROR 63 (VARIABLE 15, FILE NUMBER: 2005, LINE NUMBER: 9926) CONFIRMED IN THE PUMP HISTORY FILE ON (B)(6) 2023 (PLEASE ABOVE FOR THE DATE AND TIMES LISTED IN THE PUMP HISTORY FILE) DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. PUMP ERROR 53 CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2023 18:56:47.000 AND ON (B)(6) 2023 18:56:47.000DUE TO SOFTWARE ERROR (LINENUMBER = 5632, FILENUMBER = 2005). PUMP ERROR 63 CONFIRMED. FAILED BATT TEST ALARM NOT CONFIRMED. PUMP ERROR 53 CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. PUMP ERROR 68 NOT CONFIRMED. PUMP ERROR 49 NOT CONFIRMED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR.   PUMP ERROR 63 CONFIRMED. PUMP ERROR 53 CONFIRMED. 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. "THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS THE SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. " 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 THE ERROR CODE OF HARDWARE LOW-LEVEL FAILURES (PUMP ERROR 63). TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE ERROR OCCURRED DURING THE BASAL. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY AND STATED THAT THE PUMP REWIND WAS COMPLETED AND ALSO THE INSULIN PUMP PASSED THE SELF-TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE AND THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308596 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG4EPUX 000000763000317089

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown