BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16866313 · Received May 4, 2023

    Report

    Report Number
    2032227-2023-202619
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    September 4, 2021
    Report Date
    May 4, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.

    Description of Event or Problem · 0

    MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON APRIL 21, 2023, MEDTRONIC RECEIVED NOTICE OF A LEGAL FILING. THE REPORTER ALLEGED THAT THE FIRST EVENT OCCURRED ON OR ABOUT (B)(6) 2021, WHEN THE CUSTOMER PASSED OUT AT HOME AND WAS RUSHED BY EMERGENCY MEDICAL SERVICES TO HACKENSACK MERIDIAN HEALTH, JERSEY SHORE UNIVERSITY MEDICAL CENTER IN NEPTUNE NEW JERSEY. THE CUSTOMER REMAINED IN THE HOSPITAL UNTIL (B)(6) 2021. THE BLOOD SUGAR VALUE ON ADMISSION WAS 1095MG/DL, AND THE CUSTOMER HAD AN ACUTE KIDNEY INJURY, HYPERKALEMIA, AND SEVERE ACIDOSIS. THE CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS TREATED WITH AN INSULIN DRIP. ON ADMISSION, THE CUSTOMER'S SERUM GLUCOSE WAS 1186MG/DL. THE INSULIN PUMP WAS REMOVED IN THE EMERGENCY DEPARTMENT BUT WAS GIVEN BACK TO THE CUSTOMER WHEN DISCHARGED. THE CUSTOMER SUSTAINED A MASSIVE HEART ATTACK, AND KIDNEY FAILURE, AND HAD 2 STENTS PUT IN. IT WAS STATED THAT THE INSULIN PUMP HAD A DAMAGED RETAINER RING AND A CRACKED CASING. THE USE OF THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT AND THE STATUS OF THE AUTO-MODE FEATURE WAS UNKNOWN. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE INSULIN PUMP WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543489 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4YJQW 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R| O FRN-MMT-332A-RSVR, UNOMED INF SET