BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12335761 · Received August 18, 2021

    Report

    Report Number
    2032227-2021-181986
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    August 9, 2021
    Report Date
    January 23, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000367046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINED ON (B)(6) 2021 INSULIN PUMP ALARMED PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 AND PUMP ERROR 68. DEVICE PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPECIFIC RANGE. NO POWER ANOMALIES NOTED DURING TESTING OR IN THE DEVICE TRACE DOWNLOAD. NO PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 OR PUMP ERROR 68 NOTED DURING TEST. CONFIRMED IN THE DEVICE DOWNLOADED HISTORY THE DEVICE ALARMED PUMP ERROR 4 ON (B)(6) 2021 00:00:01.000 AND PUMP ERROR 63 VARIABLE 14 ON(B)(6) 2021 00:00:01.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2. CONFIRMED IN THE DEVICE DOWNLOADED HISTORY THE DEVICE ALARMED PUMP ERROR 23 ON (B)(6) 2021 00:00:34.000, PUMP ERROR 49 ON (B)(6) /2021 00:01:21.000 AND PUMP ERROR 68 ON(B)(6) 2021 00:01:29.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2. NO MOISTURE DAMAGE NOTED TO MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED CASE ABOVE THE ARROW AND BATTERY CAP ICON. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 OR PUMP ERROR 68 NOTED DURING TEST. CONFIRMED IN THE DEVICE DOWNLOADED HISTORY THE DEVICE ALARMED PUMP ERROR 4 ON (B)(6) 2021 00:00:01.000 AND PUMP ERROR 63 VARIABLE 14 ON (B)(6) 2021 00:00:01.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2. CONFIRMED IN THE DEVICE DOWNLOADED HISTORY THE DEVICE ALARMED PUMP ERROR 23 ON (B)(6) 2021 00:00:34.000, PUMP ERROR 49 ON (B)(6) 2021 00:01:21.000 AND PUMP ERROR 68 ON (B)(6) 2021 00:01:29.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. S/W VERSION 4.11D. RETAINER RING=BLACK. CUSTOMER COMPLAINED ON (B)(6) 2021 PUMP ALARMED PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 AND PUMP ERROR 68. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO POWER ANOMALIES NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. NO PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 OR PUMP ERROR 68 NOTED DURING TEST. CONFIRMED IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 4 ON (B)(6) 2021 00:00:01.000 AND PUMP ERROR 63 VARIABLE 14 ON (B)(6) 2021 00:00:01.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB 2 BOARD. CONFIRMED IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 23 ON (B)(6) 2021 00:00:34.000, PUMP ERROR 49 ON (B)(6) 2021 00:01:21.000 AND PUMP ERROR 68 ON (B)(6) 2021 00:01:29.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB 2 BOARD. NO MOISTURE DAMAGE NOTED TO MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED CASE ABOVE THE ARROW AND BATTERY CAP ICON. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 4, PUMP ERROR 63, PUMP ERROR 23, PUMP ERROR 49 OR PUMP ERROR 68 NOTED DURING TEST. CONFIRMED IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 4 ON (B)(6) 2021 00:00:01.000 AND PUMP ERROR 63 VARIABLE 14 ON (B)(6) 2021 00:00:01.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB 2 BOARD. CONFIRMED IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 23 ON (B)(6) 2021 00:00:34.000, PUMP ERROR 49 ON (B)(6) 2021 00:01:21.000 AND PUMP ERROR 68 ON (B)(6) 2021 00:01:29.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB 2 BOARD. 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

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (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 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236416 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 HG555FE 000000763000367046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown