BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12265903 · Received August 3, 2021

    Report

    Report Number
    2032227-2021-175516
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 24, 2021
    Report Date
    April 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Removal / Correction Number
    Z-0956-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = MISSING. CUSTOMER COMPLAINT: EVENT DATE: (B)(6) 2021. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A CRACK PARALLEL TO BELT CLIP. FUNCTIONAL TESTING TO BE PERFORMED/COMPLETED: THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A MISSING RESERVOIR TUBE O-RING, A MISSING DISPLAY WINDOW/COVER, A BROKEN RESERVOIR TUBE LIP, A MISSING RETAINER AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE TEST P-CAP/RESERVOIR DOES NOT LOCK IN PLACE AND UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO MISSING RETAINER, MISSING RESERVOIR TUBE O-RING AND BROKEN RESERVOIR TUBE LIP. DEVICE POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED. DEVICE PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. DEVICE HISTORY FILE/TRACES DOWNLOAD WAS SUCCESSFUL USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WAS WITHIN SPECIFICATION RANGE. THE INSULIN PUMP WAS MONITORED AND NO UNEXPECTED POWERING OFF OR BLANK DISPLAY NOTED. THERE WAS NO UNEXPECTED POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING THE TESTING. HOWEVER, REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:55:00.000 ALARMALERTNOTIFICATION. (B)(6) 2021 05:05:00.000 ALARMALERTNOTIFICATION. REPLACE BATTERY NOW ALARM WAS RECORDED ON: (B)(6) 2021 05:26:00.000 ALARMALERTNOTIFICATION. (B)(6) 2021 05:36:00.000 ALARMALERTNOTIFICATION. AND POWER LOSS ALARM WAS RECORDED ON: (B)(6) 2021 05:37:21.000 ALARMALERTNOTIFICATION. (B)(6) 2021 05:37:33.000 ALARMALERTNOTIFICATION. (B)(6) 2021 05:37:38.000 ALARMALERTCLEARED. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO LOOSE ELECTRONIC COMPONENTS OR MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FAILURE ANALYSIS SUMMARY: THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT, A MISSING RESERVOIR TUBE O-RING, A BROKEN RESERVOIR TUBE LIP AND A MISSING RETAINER. THE TEST P-CAP/RESERVOIR DOES NOT LOCK PROPERLY INSIDE THE RESERVOIR TUBE. DEVICE POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE PUMP WAS MONITORED FOR SEVERAL HOURS AND NO UNEXPECTED POWERING OFF OR BLANK DISPLAY 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 REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0956-2020. 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 · 1

    (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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THAT THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER REPORTED THAT DISPLAY WAS BLANK CURRENTLY. INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169096 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3G5L8 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female