BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 15891870 · Received December 1, 2022

    Report

    Report Number
    2032227-2022-368312
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    March 9, 2022
    Report Date
    November 30, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ON (B)(6) 2022 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: PUMP BROKEN CLOSE TO BATTERY PLACE. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. AFTER MULTIPLE BATTERY REPLACEMENT UNIT PERSISTED ON BLANK DISPLAY. PUMP RECEIVED WITH BLANK DISPLAY DUE TO CRACKED CASE BEHIND THE PUMP AT THE BATTERY COMPARTMENT CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. THE BATTERY TUBE ASSEMBLY WAS PUSH BACK IN THE RIGHT POSITION, MONITORED AND NO BLANK DISPLAY NOTED. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUS SOFTWARE) FOR REFERENCE. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. PUMP PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, SELF TEST AND DISPLACEMENT TEST. NO BLANK DISPLAY, LOW BATTERY ALARMS OR UNEXPECTED BATTERY POWER LOSS NOTED DURING TESTING. THE POWER MANAGEMENT GRAPH IS WITHIN SPEC. UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, MISSING DISPLAY WINDOW COVER, CRACKED KEYPAD AT SELECT BUTTON, MISSING SERIAL NUMBER LABEL AND SCRATCHED CASE. IN CONCLUSION, UNIT WAS RECEIVED WITH A BLANK DISPLAY DUE TO CRACKED CASE IN MULTIPLE LOCATIONS CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. AFTER POSITIONING THE BATTERY TUBE IN PLACE UNIT POWERED BACK ON AND THE TESTING OF THE UNIT WAS SUCCESSFUL. CUSTOMER CONCERN WAS CONFIRMED DURING VISUAL INSPECTION WHEN CRACKED CASE (BATTERY TUBE) AND CRACKED BATTERY TUBE THREADS WERE NOTED. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS BROKEN CLOSE TO BATTERY PLACE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NEITHER BEEN BUMPED NOR DROPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770939 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown