BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 16077237 · Received December 30, 2022

    Report

    Report Number
    2032227-2022-391690
    Event Type
    Death
    Date Received
    December 30, 2022
    Date of Event
    August 2, 2019
    Report Date
    April 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    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. ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Description of Event or Problem · 0

    COMPLAINTS TEXT (B)(6) 2022, 12:10:07, ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT (B)(6) 2022, 12:03:56, DIAZR52 CORRECTION ON NOTE: REFERENCED REPORT PROVIDED TO MEDTRONIC PFS ON 12/19/2022- FORWARDED TO MEDTRONIC 24-HOUR TECHNICAL SUPPORT DEPARTMENT / INCIDENT DATE UNKNOWN. COMPLAINTS TEXT (B)(6) 2022, 12:00:06, ERP_RFC_USER RELATED SVN (B)(4), COMPLAINTS TEXT (B)(6) 2022, 11:52:38, ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT (B)(6)2022, 11:52:16, DIAZR52 UNSUCCESSFUL 1ST ATTEMPT I CONTACTED THE CUSTOMER'S NEXT OF KIN (TO FURTHER DISCUSS THE REFERENCED REPORT) BUT I WAS UNABLE TO LEAVE VM THE 24-HOUR TECHNICAL SUPPORT SOLUTIONS TEAM WILL MAKE AN ADDITIONAL ATTEMPT TO CONTACT THE CUSTOMER'S NEXT OF KIN AT THIS TIME . IF CUSTOMER'S NEXT OF KIN CALLS BACK, PLEASE OFFER TROUBLE SHOOTING, GATHER AND UPDATE COMPLAINT DETAILS( BG, INCIDENT DATE, WEIGHT, ETC. NOTE: USED (B)(6) 2019 AS INCIDENT DATE, LAST PHONE INTERACTION WAS 08/01/2019 ¿REASON FOR USE OF ¿OTHER¿ FOR MISSING LOT REASON: LOT NUMBERS AT TIME OF PASSING COULD NOT BE DETERMINED AND WERE NOT PROVIDED¿. COMPLAINTS TEXT (B)(6) 2022, 11:49:34, DIAZR52 REFERENCED REPORT PROVIDED TO MEDTRONIC INSERT DEPARTMENT/TEAM ON (B)(6) 2022- FORWARDED TO MEDTRONIC 24-HOUR TECHNICAL SUPPORT DEPARTMENT. INCIDENT DATE UNKNOWN, REPORT: OUR RECORDS SHOW THAT (B)(6) PASSED AWAY IN 2019. END REPORT: ACCOUNT MARKED AS DECEASED, UPDATED GE NOTE, CEASING ALL MARKETING COMMUNICATION, WARRANTY DATE TO REFLECT THE DATE OF PASSING. NOTIFICATION DATE OF PASSING. UNABLE TO VERIFY CURRENT PART NUMBER/SERIAL NUMBER AT THE TIME OF THE EVENT, LOCATED INFORMATION FROM THE LAST AVAILABLE CALL LOGS AND/OR SALES ORDER/SHIPMENT. (B)(6).

    Description of Event or Problem · 0

    THIS CASE IS NON REPORTABLE SINCE THE CAUSE OF THE DEATH WAS NOT RELATE TO THE PRODUCT AND THERE IS NO OTHER INFORMATION WHICH IS REASONABLY SUGGEST THAT THE PRODUCT INSULIN PUMP IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410676 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG25793

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death