BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12545229 · Received September 29, 2021

    Report

    Report Number
    2032227-2021-199203
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 25, 2021
    Report Date
    June 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT RETURNED PUMP FOR ALLEGED PUMP ERROR 63 OBSERVED ON 25-SEP-2021. THE PUMP PASSED THE DISPLACEMENT TEST. PUMP FAILED SELF TEST DUE TO PUMP ERROR 63. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES UTILIZING THUS. THE FOLLOWING ALERT/ALARMS WERE NOTED ON EVENT DATE: PUMP ERROR 63 ON 09/25/2021 19:29:39.000 WITH VARIABLE 03, PUMP ERROR 54 ON 09/25/2021 19:13:11.000, AND PUMP ERROR 3 ON 09/25/2021 19:13:13.000. KEYPAD OVERLAY WAS PEELED AND KEYPAD TRACES WERE INSPECTED U1 AND FOUND CRACKED SOLDER JOINTS ON PIN 3 AND 4. CONFIRMED PUMP ERROR 54 (FILENUMBER = 32122 LINENUMBER = 1421) DUE TO SOFTWARE ANOMALY. PUMP ERROR 3 WAS A CONSEQUENCE OF PUMP ERROR 54. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE D¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, AND CRACKED RETAINER. PUMP ERROR 63 VARIABLE 3 CONFIRMED DUE TO CRACKED SOLDER JOINT. PUMP ERROR 3 WAS A CONSEQUENCE OF PUMP ERROR 54. PUMP ERROR 54 CONFIRMED DUE TO SOFTWARE ANOMALY. 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

    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. FOLLOW-UP NUMBER 1 WAS INCORRECTLY SUBMITTED AS ADDITIONAL INFORMATION SUPPLEMENTAL INSTEAD OF DEVICE EVALUATION. INFORMATION HAS BEEN UPDATED IN SECTION H1 WITH THIS FOLLOW-UP THROUGH THE CORRECTION SUPPLEMENTAL. ALSO, INFORMATION HAS BEEN ADDED WHICH WAS MISSED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION H3 OF THIS REPORT.

    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 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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR. PUMP ERROR OCCURRED TWICE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442701 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3FF9F 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown