BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 11213870 · Received January 22, 2021

    Report

    Report Number
    2032227-2021-106953
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    January 19, 2021
    Report Date
    November 7, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER: BLACK ON (B)(6) 2021 CUSTOMER REPORTS: NEED HELP IN RESET AUTOMODE BECAUSE OF EXIT DUE TO HIGH BG EVENT. AT THE TIME OF CALL BLOOD GLUCOSE WAS IN NORMAL RANGE, IT WAS 150 MG/DL. AUTOMODE ON AND ACTIVATED. AUTOMODE ISSUE WAS RESOLVED DURING CALL WITH TECHNICIAN. RFR CODES: HARM REPORTED, WITH NO ALLEGATION OF DEVICE DEFICIENCY DEVICE HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK. PER VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, CASE AND KEYPAD OVERLAY. THE P-CAP / RESERVOIR LOCKED PROPERLY DURING TESTING. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE PASSED SELF-TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT TEST. NO UNEXPECTED ERRORS OR ALARMS NOTED DURING TESTING. DURING DOWNLOAD REVIEW, NO EVIDENCE OF DATA WAS FOUND FOR THE COMPLAINT REPORT DATE OF (B)(6) 2021 DUE TO OVERWRITTEN FILES. HOWEVER, FROM (B)(6) 2021 THROUGH (B)(6) 2021 THERE WERE APROX 299 HIGH SENSOR GLUCOSE2 ALERT (816) PER LONG TRACE HISTORY FILE AND PUMP HISTORY FILE. IN SUMMARY, CUSTOMER ALLEGATION OF AUTOMODE ISSUE WAS RESOLVED DURING CALL WITH TECHNICIAN. NO CASUE OF HIGH BLOOD GLUCOSE'S AGAINST THE PUMP FOUND DURING TESTING OR VIA DATA ANALYSIS OF PUMP HISTORY FILES WAS NOTED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 · 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 400 MG/DL AND 150 MG/DL. CUSTOMER HELP IN RESET AUTO MODE BECAUSE OF EXIT DUE TO HIGH BLOOD GLUCOSE. CUSTOMER WAS TREATED WITH INSULIN PEN. CUSTOMER WAS USING AUTO MODE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110837 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG48MZ9 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FRN-UNK-RSVR,UNOMED-INF SET| FRN-UNK-RSVR,UNOMED-INF SET