BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12706162 · Received October 27, 2021

    Report

    Report Number
    2032227-2021-211147
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 20, 2021
    Report Date
    April 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    RETAINER RING=BLACK. CUSTOMER COMPLAINED ON 10/21/2021 THE PUMP ALARMED PUMP ERROR 3, PUMP ERROR 54 AND PUMP ERROR 63. DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. NO PUMP ERROR 63 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. CONFIRMED PUMP ERROR 63 VARIABLE 3 WAS NOTED IN THE HISTORY DOWNLOAD ON 10/20/2021 14:35:17.000 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 3 ON 10/20/2021 14:16:33.000 AND PUMP ERROR 54 ALARM (LINE NUMBER 1421 FILE NUMBER 32122) ON 10/20/2021 14:16:31.000 DUE TO SOFTWARE ERROR. FOUND MOISTURE DAMAGE TO PCB1 BOARD DURING VISUAL INSPECTION. NO MOISTURE DAMAGE NOTED TO MOTOR ASSEMBLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 3, PUMP ERROR 54 OR PUMP ERROR 63 NOTED DURING TEST. CONFIRMED PUMP ERROR 63 VARIABLE 3 WAS NOTED IN THE HISTORY DOWNLOAD ON 10/20/2021 14:35:17.000 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. CONFIRMED THE PUMP ALARMED PUMP ERROR 3 ON 10/20/2021 14:16:33.000 AND PUMP ERROR 54 ALARM (LINE NUMBER 1421 FILE NUMBER 32122) ON 10/20/2021 14:16:31.000 DUE TO SOFTWARE ERROR. 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 HAD MULTIPLE INSULIN PUMP ERROR ALARMS. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND INSULIN PUMP. THE CUSTOMER RAN THE SELF TEST AND IT WAS UNSUCCESSFUL THAN A NEW ERROR OCCURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606754 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG4953E 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female