BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 13838654 · Received March 21, 2022

    Report

    Report Number
    2032227-2022-168537
    Event Type
    Death
    Date Received
    March 21, 2022
    Date of Event
    September 13, 2021
    Report Date
    March 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    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. INFORMATION IN THE B5 SUMMARY REFLECTS THAT THIS MDR WAS WRITTEN IN ERROR AS IT IS A DUPLICATE REPORT.

    Description of Event or Problem · 0

    MEDTRONIC WAS CONTACTED ON OCTOBER 22, 2021, REGARDING A RECALL. THE CALLER STATE THAT THE LETTER WAS FOR HER HUSBAND WHO PASSED AWAY ON (B)(6) 2021. THE CALLER INDICATED THAT THE REASON FOR THE PASSING WAS LOW BLOOD GLUCOSE. THE DAY OF THE EVENT WAS (B)(6) 2021, IN THE AFTERNOON. THE CALLER INDICATED THAT THE CUSTOMER SUFFERED LOW BLOOD GLUCOSE AND PASSED AWAY. THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER DID NOT GO TO THE HOSPITAL OR EMERGENCY ROOM. THE CALLER SAID THAT THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 16 MG/DL AT THE TIME OF THE EVENT. THE CALLER SAID THAT THE CUSTOMER WAS NOT FEELING GOOD. THE CALLER SAID THAT THE CUSTOMER WAS NOT WEARING THE PUMP AT THE TIME OF THE EVENT. THE CUSTOMER STOPPED WEARING THE PUMP ON (B)(6) 2021, AT 9:00 PM TO SLEEP AND NOT WORRY ABOUT GOING LOW AT NIGHT. THE CALLER INDICATED THAT IT WAS UNKNOWN IF THERE WERE OTHER HEALTH ISSUES WITH THE CUSTOMER. THE CALLER INDICATED THAT THE PUMP AND ALL SUPPLIES AND METERS HAVE BEEN THROWN AWAY. THE INSULIN PUMP, AND ALL THE SUPPLIES WILL NOT BE RETURNING TO MEDTRONIC FOR ANALYSIS.

    Description of Event or Problem · 0

    THIS MDR 2032227-2022-168537 WAS SUBMITTED IN ERROR. A REFERENCE CASE WITH THE SAME DEATH EVENT WAS INITIALLY SUBMITTED UNDER MDR 2032227-2021-211943.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516594 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1LMEJ 000000643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death FRN-UNK-RSVR, UNOMED INF SET