BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12030398 · Received June 20, 2021

    Report

    Report Number
    2032227-2021-158775
    Event Type
    Malfunction
    Date Received
    June 20, 2021
    Date of Event
    May 30, 2021
    Report Date
    May 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, SELF TEST AND P-CAP/RESERVOIR DOES LOCK PROPERLY. HISTORY/TRACE DOWNLOADS WERE SUCCESSFUL USING THUS SOFTWARE. PUMP ERROR 54 ((B)(6)), ESF#: ESF (B)(4), WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF (B)(6) 2021 11:22:11.000 DUE TO SOFTWARE ISSUES. PUMP ERROR 53 ((B)(6)), ESF#: ESF 2610666, WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF (B)(6) 2021 11:26:50.000 DUE TO POSSIBLE SOFTWARE ISSUES. PUMP ERROR 3 CONFIRMED ON (B)(6) 2021 11:22:13.000 IN CONSEQUENCE OF PUMP ERROR 54. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, CRACKED CASE (BATTERY TUBE) AND BATTERY TUBE THREADS - CRACKED. NO MOISTURE DAMAGE NOTED ON ELECTRICAL BOARD 1/ELECTRICAL BOARD 2 NOTED UPON VISUAL INSPECTION OF COMPONENTS. PUMP ERROR 54 ((B)(6)), ESF#: ESF (B)(4), CONFIRMED TO DUE SOFTWARE ERRORS. PUMP ERROR 53((B)(6)), ESF#: ESF (B)(4), CONFIRMED DUE TO SOFTWARE ERRORS, AND PUMP ERROR 3, CONFIRMED ON (B)(6)2021 11:22:13.000, WAS A CONSEQUENCE OF PUMP ERROR 54. 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. 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. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER STATED THAT PUMP CLEARED AND REWIND. CUSTOMER STATED THAT ALARM AGAIN OCCURRED. 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
    927116 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG47BUU 000000763000317140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown