BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12049197 · Received June 23, 2021

    Report

    Report Number
    2032227-2021-160426
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 17, 2021
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A MISSING RESERVOIR TUBE O-RING, A BROKEN RESERVOIR TUBE LIP, A MISSING RETAINER, A PARTIALLY BROKEN BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. PUMP WAS ALSO RECEIVED WITH KEYPAD UNRESPONSIVE. UNABLE TO PERFORM 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, KEYPAD VOLTAGE TEST AND DAT DUE TO KEYPAD UNRESPONSIVE. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO KEYPAD UNRESPONSIVE. THE KEYPAD OVERLAY WAS PEELED OFF AND FOUND NO CORROSION OR MOISTURE DAMAGE FOUND ON THE KEYPAD ASSEMBLY. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE J1/PCBA 1 CONNECTOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A TEST CASE WAS USED, THE ORIGINAL PCBA 2 WAS INSTALLED AND SWAPPED OUT WITH A WORKING TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND NO KEYPAD UNRESPONSIVE NOTED. A TEST CASE WAS USED, THE ORIGINAL PCBA 2 WAS RE-INSTALLED AND SWAPPED OUT WITH A WORKING TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE AA 1.5V BATTERY. THE PUMP WAS ABLE TO NAVIGATE THE MENU AND CONTINUED TESTING AND DOWNLOAD. THE PUMP PASSED THE SELF TEST. NO KEYPAD UNRESPONSIVE NOTED WHEN USING A TEST PCBA1. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 63 ALARMS (VARIABLE INFO = 0C) ON: (B)(6) 2021 05:36:45.000, ON (B)(6) 2021 05:46:01.000, ON (B)(6) 2021 05:48:04.000, ON (B)(6) 2021 05:54:37.000, ON (B)(6) 2021 05:56:42.000, ON (B)(6) 2021 05:59:34.000 AND ON (B)(6) 2021 06:09:00.000. PER R&D ENGINEER, PUMP ERROR 63 ALARM (VARIABLE INFO = 0C) WAS GENERATED DUE TO ARM WATCHDOG FAILURE. SUSPECTING HW ISSUE. PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 11:28:53.000 AND ON (B)(6) 2021 12:31:09.000. PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 11:28:53.000, ON (B)(6) 2021 11:29:06.000. ON (B)(6) 2021 12:31:09.000, ON (B)(6) 2021 12:31:49.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 11:29:1, ON (B)(6) 2021 12:30:52.000 AND ON (B)(6) 2021 12:32:01.000. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE CONFIRMED, PROBLEM ISOLATED ON THE ELECTRONIC ASSEMBLY. UNABLE TO LOCK A TEST P-CAP INTO THE RESERVOIR COMPARTMENT DUE TO A MISSING RETAINER, A MISSING RESERVOIR TUBE O-RING AND A BROKEN RESERVOIR TUBE LIP. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A KEYPAD OVERLAY PEELING AND A SCRATCHED CASE. A MISSING RETAINER, A MISSING RESERVOIR TUBE O-RING AND A BROKEN RESERVOIR TUBE LIP WERE CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO KEYPAD UNRESPONSIVE. KEYPAD UNRESPONSIVE WAS CONFIRMED DUE TO CORROSION ON THE J1/PCBA 1 CONNECTOR. A TEST CASE WAS USED AND CONTINUED TESTING AND DOWNLOAD. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 63 ALARMS (VARIABLE INFO = 0C). PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 63 ALARMS (VARIABLE INFO = 0C), SUSPECTING HW ISSUE. 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 · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR AND PUMP ERROR ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED INSULIN PUMP HAD CRACK IN THE BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952064 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3FE8U 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown