BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 15603409 · Received October 14, 2022

    Report

    Report Number
    2032227-2022-348702
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 28, 2022
    Report Date
    July 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. SUCCESSFULLY UTILIZED THUS TO DOWNLOAD HISTORY/TRACE FILES. VERIFIED THE PUMP ALARMED NO DELIVERY DURING BASAL/BOLUS/PRIMING IN PUMP DOWNLOADED HISTORY NEAR EVENT DATE 25 TIMES. LISTED BELOW ARE THE DATES/TIMES OF NO DELIVERY ALARMS LISTED ON OR NEAR EVENT DATE ALONG WITH DURING BASAL/BOLUS/PRIMING: 2 NO DELIVERY ALARM DURING BASAL: STARTING ON 09/21/2022 19:26:00.000 ENDING ON 09/21/2022 19:36:00.000 1 NO DELIVERY ALARM DURING PRIMING: STARTING ON 09/21/2022 19:44:22.000 3 NO DELIVERY ALARM DURING BASAL: STARTING ON 09/21/2022 21:14:00.000 ENDING ON 09/22/2022 09:23:00.000 2 NO DELIVERY ALARM DURING BOLUS: STARTING ON 09/22/2022 09:31:23.000 ENDING ON 09/23/2022 09:45:58.000 2 NO DELIVERY ALARM DURING BASAL: STARTING ON 09/23/2022 09:55:00.000 ENDING ON 09/23/2022 19:42:00.000 3 NO DELIVERY ALARM DURING BOLUS: STARTING ON 09/24/2022 10:12:56.000 ENDING ON 09/24/2022 10:16:54.000 3 NO DELIVERY ALARM DURING PRIMING: STARTING ON 09/24/2022 10:29:22.000 ENDING ON 09/24/2022 10:45:00.000 6 NO DELIVERY ALARM DURING BASAL: STARTING ON 09/24/2022 17:16:00.000 ENDING ON 09/24/2022 17:57:01.000 1 NO DELIVERY ALARM DURING BOLUS: STARTING ON 09/25/2022 08:06:36.000 2 NO DELIVERY ALARM DURING BASAL: STARTING ON 09/25/2022 08:27:00.000 ENDING ON 09/25/2022 10:53:00.000 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. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY. PUMP PASSED FUNCTION TESTING. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. NO DELIVERY ALARM NOT 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

    (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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN 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. 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 EXPERIENCED INSULIN FLOW BLOCKED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN DID NOT EXIT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888234 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL HG65AAY 000000763000317195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown