BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12814063 · Received November 15, 2021

    Report

    Report Number
    2032227-2021-218462
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    November 8, 2021
    Report Date
    May 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SOFTWARE 4.11D. RETAINER RING BLACK. THE CUSTOMER ALLEGED THE DEVICE ALARMED PUMP ERROR 3, PUMP ERROR 67, PUMP ERROR 49, PUMP ERROR 24, PUMP ERROR 68, AND PUMP ERROR 4 ON NOVEMBER 08, 2021. DEVICE PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DELIVERY ACCURACY TEST AT 0.0873 INCHES. DEVICE HAD HIGH SLEEP CURRENT MEASUREMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS. THE FOLLOWING PUMP ERRORS WERE CONFIRMED IN THE FORMATTED HISTORY FILE: PUMP ERROR 3 09/28/2021 08:36:23.000; PUMP ERROR 67 09/28/2021 08:39:22.000; PUMP ERROR 49 09/28/2021 08:36:25.000, 09/28/2021 08:39:06.000, 09/28/2021 08:40:32.000 , 09/28/2021 08:48:14.000, 09/28/2021 08:57:57.000, 09/28/2021 08:58:13.000, 09/28/2021 08:58:52.000, AND 09/28/2021 08:59:09.000. PUMP ERROR 24 09/28/2021 08:59:09.000; PUMP ERROR 68 09/28/2021 08:36:25.000, 09/28/2021 08:39:06.000, 09/28/2021 08:40:32.000, 09/28/2021 08:57:57.000; AND PUMP ERROR 4 09/28/2021 08:39:20.000. THE POWER MANAGEMENT TOOL INDICATED ABNORMAL BEHAVIOR OF THE LITHIUM BACKUP BATTERY LOADED VOLTAGE AS SHOWN ON THE POWER MANAGEMENT GRAPH. PUMP ERROR 3, PUMP ERROR 67, PUMP ERROR 49, PUMP ERROR 24, PUMP ERROR 68, AND PUMP ERROR 4 WERE ISOLATED TO THE ELECTRONIC ASSEMBLY. DEVICE HAD HIGH SLEEP CURRENT MEASUREMENT AND ABNORMAL BEHAVIOR ON THE POWER MANAGEMENT TOOL, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. DURING VISUAL INSPECTION, THE ELECTRONIC ASSEMBLY WAS CORRODED. THE MOTOR HAD MOISTURE DAMAGE. NO DAMAGE NOTED ON THE FORCE SENSOR. DEVICE ERROR 3, PUMP ERROR 67, PUMP ERROR 49, PUMP ERROR 24, PUMP ERROR 68, AND PUMP ERROR 4 WERE 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 640G INSULIN INFUSION INSULIN PUMP, WHICH IS NOT MARKETED IN THE INSULIN PUMPED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION INSULIN PUMP, WHICH IS MARKETED IN THE INSULIN PUMPED STATES.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716078 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG430ZY 000000763000317140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown