BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13665439 · Received March 4, 2022

    Report

    Report Number
    2032227-2022-120854
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    March 2, 2022
    Report Date
    July 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON (B)(6) 2022 THE CUSTOMER REPORTED A BLANK DISPLAY AND EXPOSURE TO WATER. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED MIDDLE (ENTER) KEYPAD BUTTON. UNIT PASSED DISPLACEMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS; IT FAILED SLEEP CURRENT MEASUREMENT TEST. NO UNEXPECTED BLANK DISPLAYS WERE NOTED DURING TESTING. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. NO PUMP ERROR 25 WAS NOTED DURING TESTING, IN THE PUMP HISTORY FILE, IN THE LONG TRACE FILE, OR IN THE POWER MANAGEMENT GRAPH. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, THERE IS CORROSION IN/AROUND THE FOLLOWING: PCBA2--J1, LCD FLEX CABLE TERMINAL. IN SUMMARY, THE CUSTOMER¿S REPORT OF A BLANK DISPLAY WAS NOT CONFIRMED BUT THAT OF EXPOSURE TO WATER WAS CONFIRMED DURING TESTING. THE HIGH SLEEP CURRENT MEASUREMENT IS DUE TO THE MOISTURE DAMAGE AT PCBA2 J1-LCD FLEX CABLE INTERFACE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    RETAINER RING=BLACK. ON 03/02/2022 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: PATIENT CALLED IN REGARDING WITH THE OPEN BOOK WITH A X, WHICH IS THE CRITICAL PUMP ERROR. CRITICAL PUMP ERROR/OPEN BOOK IMAGE. DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE WAS DOWNLOADED SUCCESSFULLY USING (THUS SOFTWARE) FOR REFERENCE. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR AROUND THE COMPLAINT DATE THAT MIGHT OF TRIGGER THE REASON COMPLAIN. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. DEVICE PASSED SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK) DURING TESTING. THE ADAPT TOOL REVEALS THAT ON 03/02/2022 AT 18:30:001 HOUR PUMP ERROR 63 WAS RECORDED. PER R&D INVESTIGATION PUMP ERROR 63 WAS GENERATED DUE TO RF CHIP ERROR. VARIABLE INFO=15. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. PROCEED IT BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLY. ALL CONNECTORS WERE PLUGGED IN PROPERLY AND NO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLIES. DEVICE RECEIVED WITH CRACKED KEYPAD AT SELECT BUTTON. IN CONCLUSION, CUSTOMER ALLEGATIONS ARE NOT CONFIRMED. DEVICE POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND WAS TESTED SUCCESSFULLY. HOWEVER, DURING DOWNLOAD REVIEW PUMP ERROR 63 ALARMS WERE RECORDED DUE TO WATCH RF CHIP ERROR. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. 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 RECEIVED THE OPEN BOOK IMAGE WITH REX ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563712 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4MQRK 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male