BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 18472993 · Received January 9, 2024

    Report

    Report Number
    2032227-2024-103775
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 21, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08720 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE 18-DEC-2023. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: 11/26/2023 09:17:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:27:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. 11/26/2023 09:38:38.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:39:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. 11/26/2023 09:39:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:41:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:42:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:47:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:48:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/26/2023 09:48:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-DEC-2023 IN THE FORMATTED HISTORY FILE. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM AND KEYPAD ANOMALY WERE NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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 AN INSULIN FLOW BLOCKED ALARM. IT WAS ALSO REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE HARDER TO PRESS. NO FURTHER DETAILS WERE PROVIDED. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605029 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG47J5V 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male