BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884XC 780G US MG CLIN

    MDR report key: 13546935 · Received February 16, 2022

    Report

    Report Number
    2032227-2022-114653
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300045561302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 53 ALARM FOUND ON (B)(6) 2022. THE PUMP PASSED THE SELF TEST AND THE DISPLACEMENT TEST. THE PUMP WAS SUCCESSFULLY DOWNLOADED USING THUMP. NO UNEXPECTED PUMP ERROR 53 ALARMS OCCURRED DURING TESTING HOWEVER, A REVIEW OF THE HISTORY FILES SHOWS ONE (1) PUMP ERROR 53 ALARM (LINENUMBER 65535 FILENUMBER (B)(4))TRIGGERED ON (B)(6) 2022 AT 04:23 AND TWO (2) PUMP ERROR 53 ALARMS TRIGGERED ON (B)(6) 2022 AT 04:22 (LINENUMBER 0 FILENUMBER (B)(4)) AND 04:35 (LINENUMBER 1468 FILENUMBER (B)(4)), FAULT ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR NOTED. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 53 ALARM IS CONFIRMED AND IS ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS. (B)(4). 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 PUMP ERROR ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. FILL CANNULA WAS RECORDED IN DAILY HISTORY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264576 PUMP MMT-1884XC 780G US MG CLIN ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884XC A000831174 000076300045561302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown