BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 15049029 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-291567
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    March 29, 2019
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. Z-0955-2020. (B)(4). S/W 2.8C. THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT 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 TEST AT 0.08745 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND CRACKED RETAINER. DATA ANALYSIS: (DATE OF CUSTOMER PASSING: (B)(6) 2019. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 29.975 .(B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 25.7. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 9.125. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2019 DAILYTOTALOFALLINSULINDELIVERED = 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."

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2019 IN HOSPICE CARE DUE TO CARDIAC ARREST. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2019 AND THEN ADMITTED TO HOSPICE ON (B)(6) 2019 DUE TO CARDIAC ARREST AND WAS ON LIFE SUPPORT. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE CALLER STATED THAT THE CUSTOMER HAD REALLY LOW BLOOD GLUCOSE A MONTH EARLIER AND HAD HEART ATTACKS IN PAST THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS IN 80 MG/DL TO 90 MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH AND AUTO MODE WAS NOT ACTIVE. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241577 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1KTW3 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Death FRN-UNK-RSVR, UNOMED SET