BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 17538928 · Received August 14, 2023

    Report

    Report Number
    2032227-2023-254280
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. AFTER BATTERY INSTALLATION UNIT POWERED UP PROPERLY. HOWEVER, A CONSTANT FAILED BATT TEST ALERT NOTED AFTER MULTIPLE NEW BATTERIES. UNIT WAS CUT OPEN AND PERFORM A VISUAL INSPECTION ON ELECTRONIC ASSEMBLY INCLUDING BATTERY CONNECTORS. FAILED BATT TEST ALERT WAS NOTED 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 FAILED BATT TEST ALERT 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. THE POWER MANAGEMENT GRAPH IS WITHIN SPEC. UNIT WAS MONITORED AND NO UNEXPECTED CALIBRATION ALERTS NOTED DURING TESTING. UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, MINOR SCRATCHED LCD WINDOW AND LOOSE BATTERY CAP METAL CONTACT DUE TO MISSING 2 HEAT STAKE POST ON BATTERY CAP. IN CONCLUSION, CUSTOMER CONCERN WAS CONFIRMED WHEN FAILED BATT ALERTS WERE CONFIRMED DUE TO CRACKED CASE ON BATTERY TUBE CAUSING BATTERY TUBE NOT MAKING CONTACT WITH BATTERY CAP. IN ADDITION, COSMETIC DAMAGE AND DAMAGE BATTERY CAP WERE ALSO CONFIRMED WHEN MISSING HEAT STAKE POST ON BATTERY CAP AND CRACKED CASE (BATTERY TUBE) AND CRACKED BATTERY TUBE THREADS WERE NOTED. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 CUSTOMER RECEIVED CALIBRATIONS AT RANDOM TIMES AND BATTERY FAILED ALARM. THE CUSTOMER REPORTED PHYSICAL DAMAGE TO THE INSULIN PUMP. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE CRACK ON THE RESERVOIR COMPARTMENT ON THE TOP OF THE INSULIN PUMP. IT WAS ALSO FOUND THAT THE BATTERY CAP METAL CONTACT MISSING, OR FEWER THAN THREE RAISED DOTS CAN BE SEEN. THE CUSTOMER RECEIVED A CHANGE SENSOR AND CALIBRATION NOT ACCEPTED ALERTS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785219 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5JJR0 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female