BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15391373 · Received September 9, 2022

    Report

    Report Number
    2032227-2022-330272
    Event Type
    Death
    Date Received
    September 9, 2022
    Date of Event
    October 23, 2021
    Report Date
    September 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08740 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ALL AUDIO TONES WERE HEARD DURING THE SELF TEST PROPERLY. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY. NO UNEXPECTED AUDIO ANOMALY, ABSENCE OF AUDIO ALARMS OR PUMP ERROR 63 ALARMS IN THE FORMATTED HISTORY FILE NOTED DURING TESTING. HOWEVER, THE PUMP WAS UNABLE TO VIBRATE DURING SELF TEST. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE VIBRATOR ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE BATTERY TUBE ASSEMBLY, PCBA1, PCBA2, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. A TEST CASE WAS USED AND THE ORIGINAL PCBA1, PCBA2, INTERNAL BATTERY AND MOTOR WERE INSTALLED. POWERED THE PUMP ON USING THE AA 1.5V BATTERY AND CONTINUED TESTING. THE PUMP SUCCESSFULLY VIBRATE DURING THE SELF TEST. VIBRATE ANOMALY WAS CONFIRMED DUE TO CORROSION ON THE VIBRATOR ASSEMBLY. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.7 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. 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 WAS PASSED ON (B)(6) 2021 DUE TO HEART STOPPED. CUSTOMER STATED THAT INSULIN PUMP WAS WORN DURING AT THE TIME OF PASSING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139636 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG45M2Y 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death