BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 16152733 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-107578
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    February 21, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W 4.11E. RETAINER RING=BLACK. ON (B)(6) 2022 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: INSULIN FLOW BLOCKED. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT PASSED THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY NO DELIVERY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING THE COMPLAINT CALL. DOWNLOAD HISTORY REVIEW DID NOT RECORD NO DELIVERY ALARMS AROUND EVENT DATE. HOWEVER, THE ADAPT TOOL REVEALS MULTIPLE NO DELIVERY ALARMS WERE RECORDED ON 06/08/2021, 06/12/2021, 06/13/2021, 06/23/2021, 06/25/2021, 06/26/2021, 06/27/2021, 06/28/2021, 06/29/2021, 07/09/2021, 07/11/2021, 07/12/2021, 07/13/2021, 07/15/2021, 07/17/20211 AND ON 07/18/2021. HOWEVER, NO UNEXPECTED OR CONSTANT NO DELIVERY ALARMS WERE NOTED DURING TESTING. PROCEED IT BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC STACK. ALL CONNECTORS WERE PLUGGED IN PROPERLY AND NO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLIES DURING VISUAL INSPECTION. HOWEVER, CORRODED BATTERY TUBE NOTED DURING VISUAL INSPECTION. UNIT MAY HAVE HAD AN INTERMITTENT FAILURE NOT DETECTED DURING OUR TESTING. UNIT WAS RECEIVED WITH CRACKED CASE(BATTERY TUBE). IN CONCLUSION, NO UNEXPECTED OR CONSTANT INSULIN FLOW BLOCK ALARM NOTED DURING TESTING. UNIT MAY HAVE HAD AN INTERMITTENT FAILURE NOT DETECTED DURING OUR 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

    MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM DURING THERAPY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065787 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG59LCF 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown