BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12623214 · Received October 13, 2021

    Report

    Report Number
    2032227-2021-204843
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    October 10, 2021
    Report Date
    February 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND EXPOSURE TO MOISTURE FOUND ON (B)(6) 2021. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. NO BLANK DISPLAY NOTED. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO GENERATE POWER MANAGEMENT GRAPH DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP FAILED TO OPEN THE DOWNLOAD WINDOW AS PER BY-PASS STEPS AND DISPLAYED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM IMMEDIATELY PREVENTING DOWNLOAD OF FIRMWARE USING CREST AND OR HISTORY FILES AND TRACES USING THUS. PER R&D ENGINEER, THIS COULD HAPPEN IF THE HW TEST FAILED IN THE MUTABLE BOOTLOADER (INTERN). SUSPECTING THE HW. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE ELECTRONIC ASSEMBLY. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. BLANK DISPLAY NOT CONFIRMED. HOWEVER, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND UNABLE TO DOWNLOAD HISTORY FILES AND TRACES DUE TO CORROSION ON THE ELECTRONIC ASSEMBLY. PUMP EXPOSED TO MOISTURE 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

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR ALARM AND IT WAS NO LONGER WORKING. INSULIN PUMP POSSIBLY EXPOSED TO MOISTURE. CUSTOMER REPORTED OTHER CRITICAL PUMP ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526464 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG40CQ6 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female