BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 10520099 · Received September 11, 2020

    Report

    Report Number
    2032227-2020-175708
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    September 3, 2020
    Report Date
    January 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. PUMP PASSED DISPLACEMENT TEST AND SELF TEST. THE AUDIO TONES/BEEPS FUNCTIONED PROPERLY. NO UNEXPECTED PUMP ERROR 4, 63 ALARMS DURING TESTING. HOWEVER, PUMP ERROR 63 ALARM (VARIABLEINFO=0C) CONFIRMED IN THE PUMP HISTORY DUE TO HARDWARE 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. THE INFORMATION RELATED TO OCCUPATION HAS BEEN UPDATED AND PROVIDED IN E3 SECTION AND G2 SECTION ALSO UPDATED OF THIS REPORT.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. THE AUDIO TONES/BEEPS FUNCTIONED PROPERLY. NO UNEXPECTED PUMP ERROR 4, 63 ALARMS DURING TESTING. HOWEVER, PUMP ERROR 63 ALARM (VARIABLEINFO=C) CONFIRMED IN THE DEVICE HISTORY DUE TO BROKEN TRACE ON U1 KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURE ALARM AND A PUMP ERROR ALARM. 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
    984134 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG46UUZ 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown