BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12274014 · Received August 4, 2021

    Report

    Report Number
    2032227-2021-176433
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 25, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000393786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINED ON 07/25/2021 INSULIN PUMP ALARMED STUCK BUTTON. DEVICE PASSED SELF TEST AND DISPLACEMENT TEST. INTERMITTENT RESPONSE FROM THE BACK ARROW AND LEFT ARROW BUTTONS DUE TO CORRODED KEYPAD TRACES. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED INSULIN PUMP ALARMED STUCK BUTTON ON 07/25/2021 14:27:14.000 IN DEVICE DOWNLOADED HISTORY. DEVICE PASSED THE KEYPAD VOLTAGE TEST. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE (BATTERY TUBE). THE P-CAP/RESERVOIR DOES LOCK PROPERLY. INTERMITTENT RESPONSE FROM THE BACK ARROW AND LEFT ARROW BUTTONS DUE TO CORRODED KEYPAD TRACES. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON 07/25/2021 14:27:14.000 IN DEVICE DOWNLOADED HISTORY. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. 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 · 1

    (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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STUCK BUTTON ALARM. CUSTOMER STATED THEY DID NOT PRESS A BUTTON DOWN FOR 3 MINUTES OR LONGER. 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
    1175233 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG57ZZQ 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female