BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12876298 · Received November 25, 2021

    Report

    Report Number
    2032227-2021-222745
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    November 14, 2021
    Report Date
    April 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER COMPLAINED ABOUT THE UNIT HAVING A PUMP ERROR 3 AND PUMP ERROR 54 ON EVENT DATE OF NOV 14, 2021. DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. THE HISTORY/TRACE DOWNLOADS WERE SUCCESSFUL USING THUS SOFTWARE. PUMP ERROR 54 (NUMBER = 32122, LINE NUMBER = 1421) WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 11/14/2021 12:40:53.000, ESF#: ESF3010978. PUMP ERROR 3 WAS CONFIRMED IN THE HISTORY DOWNLOAD ON EVENT DATE 11/14/2021 12:40:55.000. PUMP ERROR 63 VARIABLE 03 WAS PRESENT IN DOWNLOAD HISTORY ON EVENT DATE 11/14/2021 14:33:15.000. PUMP ERROR 63 WAS DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE AND CRACKED KEYPAD OVERLAY. PUMP ERROR 54 AND PUMP ERROR 3 CONFIRMED DUE TO SOFTWARE ERROR. PUMP ERROR 54 (FILE NUMBER = 32122, LINE NUMBER = 1421) WAS CONFIRMED ON EVENT DATE OF 11/14/2021 12:40:53.000, ESF#: ESF3010978, PUMP ERROR 3 WAS CONFIRMED IN THE HISTORY DOWNLOAD ON EVENT DATE 11/14/2021 12:40:55.000 AND CONFIRMED PUMP ERROR 63 VARIABLE 3 WAS NOTED IN THE HISTORY DOWNLOAD ON 11/14/2021 14:33:15.000 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. 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 FROM MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR AND REWIND THE ALARM. THE PUMP DID NOT PASS THE SELF TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773837 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG4745S 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male