BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 15026196 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287588
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    December 12, 2021
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SOFTWARE VERSION = 4.11J. RETAINER RING = CLEAR. CUSTOMER RETURNED PUMP FOR ALLEGED PUMP ERROR ALARM AND SOFTWARE ERROR DETECTED ALARM FOUND ON (B)(6) 2021. INSULIN UMP SUCCESSFULLY DOWNLOADED TRACES AND HISTORY FILE USING THUS. PUMP PASSED SELF-TEST AND DISPLACEMENT TEST. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP ERROR 3 WAS FOUND IN THE PUMP DOWNLOADED HISTORY ON (B)(6) 2021 AT 13:38:45.000.SOFTWARE ERROR DETECTED ALARM (LINE NUMBER 1421 FILE NUMBER 32122 ESF# = 3010978) WAS FOUND IN THE PUMP DOWNLOADED HISTORY ON (B)(6) 2021 13:38:43.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MISSING DISPLAY WINDOW/COVER, CRACKED RETAINER, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE-CORNER OF BELT CLIP RAILS AND FADED SERIAL NUMBER LABEL. PUMP ERROR ALARM IS CONFIRMED AS A RESULT OF SOFTWARE ERROR DETECTED ALARM. SOFTWARE ERROR DETECTED ALARM (LINE NUMBER 1421 FILE NUMBER 32122) CONFIRMED ESF# = 3010978 DUE TO SOFTWARE ANOMALY 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 A MULTIPLE PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR ALARM AND WAS ABLE TO COMPLETE REWIND. CUSTOMER PERFORMED SELF TESTS AND THE TEST WAS PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614418 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG32LT9 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown