BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 16058361 · Received December 28, 2022

    Report

    Report Number
    2032227-2022-389256
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 15, 2022
    Report Date
    March 23, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    S/W - UNKNOWN. RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON (B)(6) 2022. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, AND PCBA 2. MOISTURE DAMAGE WAS FOUND ON THE FORCE SENSOR AND MOTOR. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. PER FREGER, MARK ¿ R&D ENGINEER: THE REASON FOR THE "OPEN-BOOK" WAS MAIN APPLICATION CODE CRC TEST FAILURE ( CODE 0X0000004D) IN THE INTERN BOOTLOADER. SUSPECTING THE HW. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS DUE TO CORRODED ELECTRONIC ASSEMBLY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WIDOW, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, AND PILLOWING KEYPAD OVERLAY. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6)2022 IN THE FORMATTED HISTORY FILE. (B)(6) 2022 20:17:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) (B)(6) 2022 20:21:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) (B)(6) 2022 14:12:42.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) (B)(6) 2022 23:11:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW RESERVOIR ALERT(105) (B)(6) 2022 12:43:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW RESERVOIR ALERT(105) (B)(6) 2022 16:00:11.000 ALARMALERTNOTIFICATION FAULTNUMBER = MAIN PROCESSOR COMMUNICATION ALARM (4) (B)(6) 2022 16:00:13.000 ALARMALERTNOTIFICATION FAULTNUMBER = ROM CRC ALARM (20) (B)(6) 2022 16:20:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = MAIN PROCESSOR COMMUNICATION ALARM (4) (B)(6) 2022 16:20:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = ROM CRC ALARM (20) (B)(6) 2022 16:20:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = TRACE CHECK ERROR (68) (B)(6) 2022 16:20:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6) 2022 16:20:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6) 2022 16:22:06.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. STUCK KEY ALARM CONFIRMED IN THE PUMP HISTORY FLE, PROBLEM ISOLATED TO THE KEYPAD. UNABLE TO TEST OR VERIFY NO DELIVERY ALARM AND LOW RESERVOIR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4, AND PUMP ERROR 20 WAS DUE TO CORRODED ELECTRONIC ASSEMBLY. PUMP ERROR 23, PUMP ERROR 49 AND PUMP ERROR 68 WERE EXPECTED DUE TO PUMP RESET. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED. STUCK KEY ALARM CONFIRMED. NO DELIVERY ALARM UNKNOWN. PUMP ERROR 4 CONFIRMED. PUMP ERROR 20 CONFIRMED. S/W - UNKNOWN. RETAINER RING = BLACK CASE TYPE = NGP CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON (B)(6) 2022. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, AND PCBA 2. MOISTURE DAMAGE WAS FOUND ON THE FORCE SENSOR AND MOTOR. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. PER FREGER, MARK ¿ R&D ENGINEER: THE REASON FOR THE "OPEN-BOOK" WAS MAIN APPLICATION CODE CRC TEST FAILURE ( CODE 0X0000004D) IN THE INTERN BOOTLOADER. SUSPECTING THE HW. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS DUE TO CORRODED ELECTRONIC ASSEMBLY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WIDOW, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, AND PILLOWING KEYPAD OVERLAY. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6)2022 IN THE FORMATTED HISTORY FILE. (B)(6) 2022 20:17:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) (B)(6) 2022 20:21:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) (B)(6) 2022 14:12:42.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) (B)(6) 2022 23:11:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW RESERVOIR ALERT(105) (B)(6) 2022 12:43:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW RESERVOIR ALERT(105) (B)(6) 2022 16:00:11.000 ALARMALERTNOTIFICATION FAULTNUMBER = MAIN PROCESSOR COMMUNICATION ALARM (4) (B)(6) 2022 16:00:13.000 ALARMALERTNOTIFICATION FAULTNUMBER = ROM CRC ALARM (20) (B)(6) 2022 16:20:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = MAIN PROCESSOR COMMUNICATION ALARM (4) (B)(6) 2022 16:20:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = ROM CRC ALARM (20) (B)(6) 2022 16:20:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = TRACE CHECK ERROR (68) (B)(6) 2022 16:20:03.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6) 2022 16:20:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = HISTORY POINTERS BAD ALERT (49) (B)(6) 2022 16:22:06.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. STUCK KEY ALARM CONFIRMED IN THE PUMP HISTORY FLE, PROBLEM ISOLATED TO THE KEYPAD. UNABLE TO TEST OR VERIFY NO DELIVERY ALARM AND LOW RESERVOIR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4, AND PUMP ERROR 20 WAS DUE TO CORRODED ELECTRONIC ASSEMBLY. PUMP ERROR 23, PUMP ERROR 49 AND PUMP ERROR 68 WERE EXPECTED DUE TO PUMP RESET. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED. STUCK KEY ALARM CONFIRMED. NO DELIVERY ALARM UNKNOWN. PUMP ERROR 4 CONFIRMED. PUMP ERROR 20 CONFIRMED. 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

    (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. 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 A OPEN BOOK IMAGE ALARM.  TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD JUST STARTED TO COOK, WHEN THEY RECEIVED THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738762 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG63J1L

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male