BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 11972820 · Received June 10, 2021

    Report

    Report Number
    2032227-2021-154859
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    June 6, 2021
    Report Date
    May 1, 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
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER COMPLAINT: EVENT DATE: (B)(6) 2021. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A PUMP ERROR 54 ALARM, PUMP ERROR 3 ALARM AND PUMP ERROR 63 ALARM. FUNCTIONAL TESTING TO BE PERFORMED/COMPLETED: THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED CASE, A CRACKED RESERVOIR TUBE LIP, A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A CRACKED RETAINER. THE TEST P-CAP/RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. DEVICE HISTORY FILE/TRACES DOWNLOAD WAS SUCCESSFUL USING THUS. DEVICE PASSED THE DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR 54 AND PUMP ERROR 3 ALARM NOTED DURING THE TESTING. HOWEVER, PUMP ERROR 3 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:26:17.000 AND PUMP ERROR 54 ALARM ON: (B)(6) 2021 12:26:15.000 DUE TO DUE TO SOFTWARE ERROR. PUMP ERROR 63 ALARM DURING SELF TEST AND WERE FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:46:58.000, ALARM ALERT NOTIFICATION. (B)(6) 2021 12:47:11.000, ALARM ALERT CLEARED. (B)(6) 2021 12:50:42.000, ALARM ALERT NOTIFICATION. (B)(6) 2021 12:50:54.000, ALARM ALERT CLEARED. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND A BROKEN TRACE ON U1 KEYPAD ASSEMBLY WAS FOUND. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO LOOSE ELECTRONIC COMPONENTS OR MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A TEST CASE WAS USED AND CONTINUED TESTING. DEVICE PASSED THE SELF TEST. IN CONCLUSION, PUMP ERROR 63 ALARM DURING SELF TEST DUE TO BROKEN TRACE ON U1 KEYPAD ASSEMBLY. FAILURE ANALYSIS SUMMARY: THE INSULIN PUMP HAD A PUMP ERROR 3 AND PUMP ERROR 54 ALARM ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. ALSO, PUMP ERROR 63 ALARM DURING SELF TEST DUE TO BROKEN TRACE ON U1 KEYPAD 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.

    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. 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 · 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 SHOWED PUMP ERROR. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND COMPLETE INSULIN PUMP REWIND. CUSTOMER REPORTED THAT ALARM RECURRED DURING SELF TEST. IT WAS UNKNOWN IF AUTOMODE FEATURE WAS IN USE AT THE TIME OF THE EVENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876902 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3BZNU 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female