BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 12932602 · Received December 6, 2021

    Report

    Report Number
    2032227-2021-226922
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 26, 2021
    Report Date
    May 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. THE INSULIN PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY DURING THE VISUAL INSPECTION. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER ANALYSIS OF THE INSULIN PUMP HISTORY FOUND MULTIPLE PUMP ERROR 130 AND 23 ALARM: ON (B)(6) 2021 AT 13:00:42 FAULT NUMBER = MFDA ALARM (130) ON (B)(6) 2021 AT 16:33:21 UNTIL 17:25:00 FAULT NUMBER = MFDA ALARM (130), ON (B)(6) 2021 AT 11:33:43 UNTIL 15:02:00 FAULT NUMBER = MFDA ALARM(130), ON (B)(6) 2021 AT 16:40:00 FAULT NUMBER = POST-RESET RAM CRC ALARM (23), ON (B)(6) 2021 AT 16:39:36 FAULT NUMBER = POST-RESET RAM CRC ALARM (23), AND ON (B)(6) 2021 AT 16:47:16 FAULT NUMBER = POST-RESET RAM CRC ALARM (23). THE INSULIN PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO PUMP ERROR 130 OR 23 ALARM DURING TESTING. THE INSULIN PUMP MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM NOTED. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. IN SUMMARY, THE INSULIN PUMP PASSED ALL REQUIRED TESTING. CUSTOMER ALLEGED NOT CONFIRMED FOR PUMP ERROR 23 ALARM. PUMP ERROR 130 ALARM CONFIRMED IN THE INSULIN PUMP HISTORY, PROBLEM ISOLATED TO THE MOTOR 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 VIA MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED MOVEMENT IN HALL SENSOR COUNTS ERROR AND POST RESET RAM CRC ALARM. THE CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED MOVEMENT IN HALL SENSOR THRICE. THE CUSTOMER WAS ABLE TO REWIND THE PUMP, THEN THE PUMP HAD REPLACE RESERVOIR 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
    1843612 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3TNS8 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown