BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 16050084 · Received December 27, 2022

    Report

    Report Number
    2032227-2022-388517
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 19, 2022
    Report Date
    March 1, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN ADDED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. RETAINER RING: BLACK. CASE TYPE: NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON 19-DEC-2022. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. THE PUMP PASSED THE DISPLACEMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST AND SELF TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. HOWEVER, MOISTURE DAMAGE IN THE BATTERY TUBE WAS NOTED. NO FATAL CRITICAL ALARMS OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE HISTORY FILES OR TRACES, HOWEVER, OTHER ALARMS WERE FOUND NEAR THE EVENT DATE. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED KEYPAD OVERLAY, LABEL DAMAGE(SERIAL NUMBER LABEL SEVERELY FADED), CORRODED BATTERY TUBE, AND PILLOWING KEYPAD OVERLAY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS NOT OBSERVED DURING ANALYSIS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOT CONFIRMED. [4] NM_MAIN_ARM_COMM_E SYSTEMTIME 12/17/2022 8:50 [63] NM_HARDWARE_ERROR_E SYSTEMTIME 12/17/2022 8:50 [6] NM_BATT_OUT_LIMIT_E SYSTEMTIME 12/17/2022 8:53 [6] NM_BATT_OUT_LIMIT_E SYSTEMTIME 12/17/2022 8:53 [6] NM_BATT_OUT_LIMIT_E SYSTEMTIME 12/17/2022 9:08 [6] NM_BATT_OUT_LIMIT_E SYSTEMTIME 12/17/2022 9:09 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

    (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. 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, 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED CRITICAL PUMP ERROR WITH OPEN BOOK IMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED BUT ISSUES WERE UNRESOLVED, CUSTOMER WILL DISCONTINUE TO USE THE DEVICE. THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137129 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG39R94

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown