BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 13760239 · Received March 14, 2022

    Report

    Report Number
    2032227-2022-136059
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    March 9, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 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.

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK. CUSTOMER COMPLAINED ON 03/09/2022 PUMP ALARMED STUCK BUTTON. PUMP PASSED SELF TEST AND DISPLACEMENT TEST. INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO MOISTURE DAMAGE TO KEYPAD TRACES. UNIT SUCCESSFULLY DOWNLOADED TO THUS. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON 03/09/2022 14:26:37.000 IN PUMP DOWNLOADED HISTORY. UNIT PASSED THE KEYPAD VOLTAGE TEST. THE J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE (BATTERY TUBE). THE P-CAP/RESERVOIR DOES LOCK PROPERLY. CONFIRMED INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO MOISTURE DAMAGE TO KEYPAD TRACES. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING AND VERIFIED PUMP ALARMED STUCK BUTTON ON 03/09/2022 14:26:37.000 IN PUMP DOWNLOADED HISTORY. 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 STATED THAT THE INSULIN PUMP HAD A STUCK BUTTON ALARM. CUSTOMER STATED THAT THE KEYPAD BUTTON WAS UNRESPONSIVE. NO HARM WAS REQUIRED DURING MEDICAL INTERVENTION. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617688 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG4GW5R 000000763000317089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown