BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 17198082 · Received June 26, 2023

    Report

    Report Number
    2032227-2023-225121
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 4, 2023
    Report Date
    August 8, 2023
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. 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 89 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 05/28/2023 15:01:16.000. 3 NO DELIVERY ALARM DURING BASAL; START DATE 06/01/2023 10:51:00.000 END DATE 06/01/2023 12:04:24.000. 3 NO DELIVERY ALARM DURING BOLUS: START DATE 06/02/2023 07:19:12.000 END DATE 06/02/2023 12:53:54.000. 70 NO DELIVERY ALARM DURING BASAL: START DATE 06/02/2023 14:01:00.000 END DATE 06/04/2023 15:58:00.000 . 2 NO DELIVERY ALARM DURING BOLUS: START DATE 06/04/2023 18:16:46.000 END DATE 06/04/2023 18:17:18.000. 1 NO DELIVERY ALARM DURING PRIMING: START DATE 06/04/2023 18:41:10.000. 1 NO DELIVERY ALARM DURING BOLUS: START DATE 06/04/2023 18:42:41.000. 2 NO DELIVERY ALARM DURING BASAL: START DATE 06/04/2023 18:49:00.000 END DATE 06/04/2023 18:59:00.000. 1 NO DELIVERY ALARM DURING BOLUS: START DATE 06/04/2023 19:53:40.000. 1 NO DELIVERY ALARM DURING BASAL: START DATE 06/04/2023 19:54:00.000. 1 NO DELIVERY ALARM DURING BOLUS: START DATE 06/04/2023 19:54:36.000. 1 NO DELIVERY ALARM DURING PRIMING: START DATE 06/04/2023 20:09:44.000. 1 NO DELIVERY ALARM DURING BOLUS: START DATE 06/04/2023 20:11:16.000. 1 NO DELIVERY ALARM DURING PRIMING: START DATE 06/04/2023 20:11:54.000. 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: STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, AND FADED END CAP ADDRESS LABEL PUMP PASSED FUNCTION TESTING. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. NO DELIVERY ALARM NOT 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

    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. 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 REPORTED AN INSULIN FLOW BLOCK ALARM DURING FILL TUBING. TROUBLESHOOTING WAS PERFORMED AND ADVISED TO REPLACE THE PLUNGER AND MANUALLY PUSH THE PLUNGER VERY SLOWLY WHILE KEEPING THE RESERVOIR STRAIGHT AND FOUND THE INSULIN EXITED THE TUBING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USING THE INSULIN PUMP AND WILL BE RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833289 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG4A4RF 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female