BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 16146260 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-105941
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    February 12, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000393786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W VER. 4.11E. RETAINER RING = BLACK. ON (B)(6) 2022 THE CUSTOMER REPORTED BATTERY FAILED ALARMS AND PUMP ERRORS 53 AND 4. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED CASE ON THE BATTERY TUBE SIDE STARTING AT THE LEFT BELT CLIP RAIL. UNIT PASSED DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. NO UNEXPECTED ¿LOW BATTERY¿, ¿REPLACE BATTERY¿, "INSERT BATTERY", ¿BATTERY FAILED¿, OR "POWER LOSS" ERRORS WERE NOTED DURING TESTING. NO PUMP ERRORS 53 AND 4 WERE NOTED DURING TESTING EITHER. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. NO PUMP ERROR 25 WAS NOTED DURING TESTING, IN THE PUMP HISTORY FILE, IN THE LONG TRACE FILE, OR IN THE POWER MANAGEMENT GRAPH. THE ADAPT TOOL CONFIRMS MULTIPLE OCCURRENCES OF THE FOLLOWING ALERTS/ALARMS AROUND THE EVENT DATE: 58=FAILED BATTERY TEST ALARM OCCURRED (B)(6) 2022 @ 16:41:01, 16:41:17, AND 16:42:31. THE ADAPT TOOL ALSO LISTS THE FOLLOWING PUMP ERRORS THAT COULD POTENTIALLY TRIGGER A CRITICAL PUMP ERROR: PUMP ERROR 53 (FILENUMBER = 183, LINENUMBER = 151) OCCURRED (B)(6) 2022 16:40:57; PUMP ERROR 4 OCCURRED (B)(6) 2022 16:40:55. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION INSIDE THE BATTERY COMPARTMENT OR ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE UNIT. IN SUMMARY, THE CUSTOMER¿S REPORT OF BATTERY FAILED ALARMS AND PUMP ERRORS 53 AND 4 WAS CONFIRMED BY THE ADAPT TOOL. THE BATTERY FAILED ALARM AS WELL AS PUMP ERRORS 53 (FILENUMBER = 183, LINENUMBER = 151) AND 4 ARE DUE TO A SOFTWARE ISSUE. 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

    MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 4, FAILED BATT TEST, PUMP ERROR 53 OCCURRED. THERE WAS AN ALLEGATION OF HYPERGLYCEMIA AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513521 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG58870 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown