BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1885L MM780G BLE MMOL

    MDR report key: 15486960 · Received September 26, 2022

    Report

    Report Number
    2032227-2022-342759
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    December 27, 2021
    Report Date
    September 26, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP *780G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    ON (B)(6) 2021, 16:20:07 PST ICE BATCH USER (BATCH_ICE), PHONE: (B)(4), COMPLAINT: (B)(4), COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6) TAKEN BY: (B)(4) CROSS REFERENCE (B)(4) INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CST CLAIMS PUMP IS NOT DELIVERING BOLUS - BASED ON CARELINK PUMP WORKS AS NEEDED , EDUCATED CST, ADVISED TO VISIT HCP AGAIN BUT CST REFUSED BECAUSE SAID THAT THEY KNOW BETTER AND HCP HAS NO IDEA ABOUT PUMP WORKING HIGH BG/UNDER DELIVERY T/S PER DOP114-980. DETAILS OF WHAT LED UP TO EVENT: DAILY USE . PATIENT'S BG AT TIME OF INCIDENT: 12 MMOL/L. PATIENT'S CURRENT BG VALUE (AT TIME OF CALL): 12.8 MMOL/L. IS CUSTOMER CURRENTLY REPORTING ANY SYMPTOMS RELATED TO THEIR HIGH BGS: NO CUSTOMER REPORTS THEY FEEL OKAY TO T/S. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BG EVENT. CUSTOMER IS NOT CALLING BACK TO PERFORM AN HP TEST. EXPL THAT WE HAVE FORMULATED THESE TROUBLESHOOTING STEPS TO ENSURE THEIR PUMP IS COMPLETELY OPERATIONAL AND WORKING SAFELY BY COVERING COMMON FACTORS INCLUDING INFUSION SET, SITE, INSULIN, LIFESTYLE, PUMP PROGRAMMING. CUSTOMER WISHES TO CONTINUE TROUBLESHOOTING. WAS CUSTOMER USING THE MINIMED 670G/770G/780G SYSTEM WITH THE AUTO MODE/SMARTGUARD FEATURE ACTIVE AT TIME OF HIGH BG EVENT: YES EXPLAINED THE 2 HIGH BG RULE. ADV TO CONSIDER CHANGING INSULIN, RESERVOIR AND INFUSION SET. ADV TO CALL BACK FOR ASSISTANCE. WAS CUSTOMER USING THE MINIMED 670G/770G/780G SYSTEM WITH THE AUTO MODE/SMARTGUARD FEATURE ACTIVE AT TIME OF HIGH BG EVENT: YES CUSTOMER REPORTS THEY ARE UNSURE IF THEY HAVE A BACK-UP PLAN AVAILABLE. INQUIRED IF, AND HOW, CUSTOMER TREATED FOR HIGH BGS. FOUND: MANUAL MODE. RECENT HIGH BG EVENT BEGAN: DAY TO DAY 12 MMOL ISNT ALL DAY. INF WAS LAST CHANGED PRIOR TO EVENT: CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: SATISFIED SHIP: NOTHING/RETURN: NOTHING. (B)(6), INPUT DATE: 12/27/2021, WARRANTY START: 06/20/2020 WARRANTY END: 06/19/2024 BATCH - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928504 PUMP MMT-1885L MM780G BLE MMOL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885L HG5EPE1 000000763000521523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown