BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 17235807 · Received June 30, 2023

    Report

    Report Number
    2032227-2023-228467
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 10, 2023
    Report Date
    August 16, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, AND DAT AT .0867 INCHES. THE PUMP FAILED THE SELF TEST DUE TO PUMP ERROR 63. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. SUCCESSFULLY UTILIZED THUS TO DOWNLOAD HISTORY/TRACE FILES. VERIFIED THE PUMP ALARMED NO DELIVERY DURING BASAL/BOLUS/PRIMING IN PUMP DOWNLOADED HISTORY NEAR EVENT DATE 38 TIMES. LISTED BELOW ARE THE DATES/TIMES OF NO DELIVERY ALARMS LISTED ON OR NEAR EVENT DATE ALONG WITH DURING BASAL/BOLUS/PRIMING: 1 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 10:19:50.000 2 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 10:28:00.000 END DATE 06/06/2023 10:38:00.000 1 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 11:23:51.000 1 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 11:25:01.000 2 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 202311:25:31.000 END DATE 06/06/2023 11:32:37.000 2 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 11:33:00.000 END DATE 06/06/2023 11:34:00.000 5 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 11:38:30.000 END DATE 06/06/2023 12:03:30.000 1 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:05:00.000 2 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 12:08:20.000 END DATE 06/06/2023 12:08:48.000 1 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:15:00.000 3 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 12:32:26.000 END DATE 06/06/2023 12:33:44.000 1 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:36:00.000 1 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 12:37:32.000 1 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:38:00.000 1 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 2023 12:41:55.000 3 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:42:00.000 END DATE (B)(6) 2023 12:53:00.000 6 NO DELIVERY ALARM DURING BOLUS: START DATE (B)(6) 202316:50:32.000 END DATE (B)(6) 2023 12:29:22.000 4 NO DELIVERY ALARM DURING BASAL: START DATE (B)(6) 2023 12:30:00.000 END DATE (B)(6) 2023 13:57:01.000 THE FOLLOWING ALARMS/ALERTS WERE NOTED ON OR NEAR EVENT DATE: PUMP ERROR 63 ON (B)(6) 2023 06:31:07.000 WITH VARIABLE 03. KEYPAD OVERLAY WAS PEELED AND INSPECTED THE KEYPAD TRACES: FOUND CRACKED SOLDER JOINTS ON IC U1 PINS 2,3,5,AND 6. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, MISSING DISPLAY WINDOW/COVER, PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING, AND CRACKED RETAINER. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. NO DELIVERY ALARM NOT CONFIRMED. PUMP ERROR 63 CONFIRMED DUE TO CRACKED SOLDER JOINTS. UNABLE TO CONFIRM ALLEGED HIGH BG. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 294 MG/DL AT THE TIME OF THE EVENT AND RECEIVED AN INSULIN FLOW BLOCK ALARM. THE CUSTOMER STATED THAT THE PUMP WAS NOT WORKING. THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE INSULIN FLOW BLOCK ISSUE WAS RESOLVED BY COMPLETE SET CHANGE. IT WAS UNKNOWN WHETHER THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT AND THE SMARTGUARD AUTO MODE OF THE INSULIN PUMP WAS USED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447540 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3K90R 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male