BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 15796251 · Received November 15, 2022

    Report

    Report Number
    2032227-2022-360434
    Event Type
    Death
    Date Received
    November 15, 2022
    Date of Event
    June 10, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000173036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W 4.10C. RETAINER RING: CLEAR. THE CUSTOMER PASSED AWAY ON (B)(6) 2022. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0871 INCHES. THE PUMP HAD A COMPLETELY BROKEN OFF BATTERY CAP CONTACT (ALL 3 HEAT STAKE POSTS WERE BROKEN OFF). THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND A CRACKED/PARTIALLY BROKEN OFF RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE (B)(6) 2022 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE: (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0; (B)(6) 2022 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0. THE PUMP PASSED THE FUNCTIONAL TESTING. DURING VISUAL INSPECTION, BATTERY CAP DAMAGE CONFIRMED. 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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2022 DUE TO UNKNOWN REASON. CUSTOMER WAS ADMITTED IN HOSPITAL ON (B)(6) 2022. CUSTOMER WAS NOT USING INSULIN PUMP AT THE TIME OF PASSING. THE INSULIN PUMP WAS RETURNED FOR THE ANALYSIS AS WAS REPORTED ON THE BASIS OF FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705413 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG36YFQ 000000763000173036

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death FRN-RSVR-MMT-332A, UNOMED-UNK