BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 18081897 · Received November 7, 2023

    Report

    Report Number
    2032227-2023-298268
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    April 15, 2022
    Report Date
    November 6, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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. THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT, AND SELF TEST. PUMP FAILS SLEEP CURRENT TEST. REVIEWED PUMP ALARM HISTORY AND OBSERVED THE FOLLOWING ALARMS: PUMP ERROR 4, PUMP ERROR 3, PUMP ERROR 23, PUMP ERROR 49, AND PUMP ERROR 68. SUCCESSFULLY UTILIZED THUS TO DOWNLOAD HISTORY/TRACE FILES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON PCBA 1, PCBA 2, MOTOR, FORCE SENSOR, AND LCD CONNECTOR. VERIFIED THE FOLLOWING ALARMS ON EVENT DATE: PUMP ERROR 4 ON 04/15/2022 13:28:01.000, PUMP ERROR 3 ON 04/15/2022 13:28:01.000, PUMP ERROR 23 ON 04/15/2022 13:28:47.000, PUMP ERROR 49 ON 04/15/2022 13:28:03.000, AND PUMP ERROR 68 ON 04/15/2022 13:28:03.000. THE FOLLOWING POWER ALARMS/ALERTS NOTED IN DOWNLOADED HISTORY ON EVENT DATE: LOW BATTERY ALERT [104] ON 04/15/2022 11:52:00.000 AND BATTERY FAILED ALARM [58] ON 04/15/2022 13:29:17.000. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP ERROR 3 AND PUMP ERROR 4 CONFIRMED DUE TO MOISTURE DAMAGE.TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. .¿THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BATTERY TUBE THREADS - CRACKED, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, AND BATTERY CAP CONTACT MISSING. EXPOSURE TO MOISTURE CONFIRMED ON PCBA 1, PCBA 2, MOTOR, FORCE SENSOR, AND LCD CONNECTOR. SLEEP CURRENT ANOMALY, PUMP ERROR 3 AND PUMP ERROR 4 CONFIRMED DUE TO MOISTURE DAMAGE. NO PUMP ERROR 23, PUMP ERROR 49, OR PUMP ERROR 68 NOTED DURING ANALYSIS. PUMP ERROR 23, PUMP ERROR 49, AND PUMP ERROR 68 NOT CONFIRMED. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 REPORTS THERE IS FLUID IN THE BATTERY COMPARTMENT. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER STATES THE HOME SCREEN APPEARED ON THE DISPLAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350147 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown