BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 19369583 · Received May 22, 2024

    Report

    Report Number
    2032227-2024-174961
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    May 3, 2024
    Report Date
    July 10, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000393786
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. 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 0.08670 INCHES. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY DOWNLOADED COMLINK3 FILE. THERE WERE NO FATAL CRITICAL ALARMS, OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE FORMATTED HISTORY FILE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS GENERATED DUE TO USART TEST FAILURE IN THE INTERN BOOTLOADER (CODE 0X00000046) ACCORDING TO COMLINK3 FILE, SUSPECTED ON HW. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 03-MAY-2024 IN THE FORMATTED HISTORY FILE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2024 08:20:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 05/03/2024 08:26:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. 05/03/2024 11:33:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 05/03/2024 11:40:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 05/03/2024 20:38:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. INSERT BATTERY ALARM WAS FOUND ON: 05/03/2024 21:13:20.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 05/03/2024 21:13:36.000 POWER LOSS ALARM WAS FOUND ON: 05/03/2024 21:14:33.000 05/03/2024 21:14:45.000 PUMP ERROR 3 ALARM (FILE NUMBER: 2002 LINE NUMBER: 2803) WAS FOUND ON: 05/03/2024 21:11:01.000 PUMP ERROR 68 ALARM WAS FOUND ON: 05/03/2024 21:11:03.000 05/03/2024 21:13:48.000 PUMP ERROR 49 ALARM WAS FOUND ON: 05/03/2024 21:11:03.000 05/03/2024 21:11:18.000 05/03/2024 21:13:48.000 05/03/2024 21:14:02.000 PUMP ERROR 23 ALARM WAS FOUND ON: 05/03/2024 21:11:29.000 05/03/2024 21:14:21.000 POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. PUMP ERROR 3 ALARM (FILE NUMBER: 2002 LINE NUMBER: 2803) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTARTED DUE TO PUMP ERROR 3 ALARM (FILE NUMBER: 2002 LINE NUMBER: 2803). THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. ALSO, PUMP ERROR 3 ALARM (FILE NUMBER: 2002 LINE NUMBER: 2803) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. 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. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CRITICAL PUMP ERROR (OPEN BOOK IMAGE). THE CUSTOMER REPORTED NO ADVERSE EVENT. TROUBLESHOOTING WAS PERFORMED.THE EVENT INVOLVED PRODUCT(S) MMT-1780KPK. CUSTOMER REPORTED A CRITICAL PUMP ERROR/OPEN BOOK IMAGE ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1780KPK WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451660 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG61375 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male