BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 14335727 · Received May 9, 2022

    Report

    Report Number
    2032227-2022-188249
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 30, 2022
    Report Date
    August 26, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SOFTWARE VERSION 4.11E. RETAINER RING = BLACK. ON 04/30/2022 THE CUSTOMER REPORTED AN OPEN BOOK AFTER THE INSULIN PUMP FELL INTO WATER. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BATTERY TUBE THREADS, CRACKED CASE ON THE BATTERY TUBE SIDE STARTING AT THE LEFT BELT CLIP RAIL. DEVICE WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS DUE TO THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. ATTEMPT TO DOWNLOAD/UPLOAD USING CREST/THUS WAS SUCCESSFUL. THE ADAPT CONFIRMS THE FOLLOWING PUMP ERRORS THAT COULD POTENTIALLY TRIGGER A CRITICAL PUMP ERROR (OPEN BOOK IMAGE): PUMP ERROR 63 (VARIABLE INFO = 9) OCCURRED ON 04/29/2022 @ 21:29:18, 21:29:31, 21:36:50, & 21:37:02; PUMP ERROR 3 OCCURRED 04/29/2022 21:29:33 & 21:37:04; PUMP ERROR 53 (FILE NUMBER = 2005, LINE NUMBER = 5632) OCCURRED @ 04/29/2022 21:38:43.000, 04/29/2022 21:39:10.000. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, THERE IS CORROSION IN/AROUND THE FOLLOWING: ELECTRICAL BOARD 1--J6; ELECTRICAL BOARD 2--J1, LCD FLEX CABLE TERMINAL; COMPONENTS LOCATED ON THE FORCE SENSOR FLEX CABLE. IN SUMMARY, THE CUSTOMER¿S REPORT OF AN OPEN BOOK WAS CONFIRMED DURING TESTING. PUMP ERROR 63 (VARIABLE INFO = 9) AND PUMP ERROR 3 ARE DUE TO THE PIO FAILURE WHICH IS A HARDWARE ERROR AND THE PUMP ERROR 53 IS DUE TO A SOFTWARE ANOMALY. THE OPEN BOOK IS DUE TO A COMBINATION OF THE PUMP ERRORS LISTED ABOVE AND MOISTURE DAMAGE. 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 INSULIN PUMP ALARMED CRITICAL PUMP ERROR WITH OPEN BOOK IMAGE. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244237 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG43PL4 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female