BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16804787 · Received April 25, 2023

    Report

    Report Number
    2032227-2023-195262
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 5, 2023
    Report Date
    June 5, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BATTERY TUBE THREADS, CRACKED CASE ON THE BATTERY TUBE SIDE STARTING AT THE LEFT BELT CLIP RAIL, ANOTHER CRACK IN THE CASE THAT RUNS HORIZONTALLY ACROSS THE SIDE OF THE BATTERY COMPARTMENT ABOUT WHERE THE BOTTOM OF THE BATTERY COMPARTMENT IS LOCATED. THE UNIT WAS RECEIVED WITH A BATTERY CAP. THE CONTACT WAS PROPERLY ATTACHED, AND THE WELD SPOTS HOLDING THE METAL CONTACT IN PLACE WERE STILL INTACT. AFTER BATTERY INSTALLATION, A BLANK DISPLAY WAS NOTED. UNABLE TO PERFORM THE DISPLACEMENT, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS DUE TO THE BLANK DISPLAY. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE UNIT. THERE IS A CRACK, HOWEVER, AT THE BOTTOM OF THE PLASTIC WHICH HOUSES THE BATTERY COMPARTMENT. THE COPPER SLEEVE WITHIN THE BATTERY COMPARTMENT GOT PUSHED DOWNWARDS, AND AS A RESULT, THE BATTERY CAP TERMINAL DOES NOT MAKE CONTACT WITH THE BATTERY SLEEVE. THE BOARDS WERE TAKEN OUT OF THE CASE AND INSERTED INTO A KNOWN GOOD CASE. THE UNIT THEN BOOTED UP TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE). ATTEMPT TO DOWNLOAD/UPLOAD USING CREST/THUS WAS SUCCESSFUL. THE ADAPT TOOL CONFIRMS THAT A PUMP ERROR 35 OCCURRED ON 04/12/2023 @ 12:01:00. THE FORCE SENSOR ZERO OFFSET MEASURED IN SPEC = 24.3 MV . IN SUMMARY, THE CUSTOMER¿S REPORT OF A BLANK DISPLAY WAS CONFIRMED DURING TESTING. THE BLANK DISPLAY IS DUE TO THE LACK OF CONTACT BETWEEN THE BATTERY CAP CONTACTS AND THE BATTERY SLEEVE. THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND THE PUMP ERROR 35 ARE DUE TO A PROBLEM ISOLATED TO THE ELECTRONICS. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 CUSTOMER REPORTED  INSULIN PUMP HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER REPORTED BLANK DISPLAY AFTER RECEIVING NEW BATTERY CAP AND USING ALUMINUM FOIL TO ACCEPT THE BATTERY. THE CUSTOMER TRIED WITH 4 NEW BATTERY CAPS BUT THE ISSUE WAS NOT RESOLVED . NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489430 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG55UB1 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male