BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 15027799 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287905
    Event Type
    Death
    Date Received
    July 15, 2022
    Date of Event
    November 29, 2017
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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). PUMP RECEIVED NOT STUCK IN THE MANUFACTURING MODE. SW 2.8C. PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. PUMP RECEIVED WITH NO BATTERY INSTALLED. PUMP RECEIVED WITH SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED RETAINER AND MINOR SCRATCHED LCD WINDOW. DATA ANALYSIS: 11/23/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 31.7, 11/24/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 29.8, 11/25/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 49.125, 11/26/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 51.4, 11/27/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 40.75, 11/28/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 15.225, 11/29/17 DAILY TOTAL OF ALL INSULIN DELIVERED = 4.475. 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

    (B)(4). SERVICE: UPS NEXT DAY AIR LABEL DELIVERY METHOD: PRINT AND MAIL RETURN LABEL BILL RETURN SHIPPING CHARGES TO: SHIPPER'S UPS ACCOUNT. (B)(4). ACCOUNT MARKED INACTIVE/DECEASED DEVICE WARRANTY UPDATE TO REFLECT THE DATE THE PATIENT PASSED AWAY (B)(6) 2017 CREATED RETURN FOR DEVICE AS CUSTOMERS NEXT OF KIN AGREED TO RETURN. (B)(4) FROM THE MEDTRONIC (CUSTOMER SUPPORT CENTER) DEPARTMENT WAS NOTIFIED OF THE CUSTOMER PASSING BY DECEASED PATIENT¿S NEXT OF KIN: ----START E-MAIL---- HOWDY, YA¿LL: PLEASE REACH OUT TO WIDOWER,(B)(6), WHO WANTS TO REPORT THE PASSING OF HIS WIFE (B)(6). WANTS TO KNOW WHAT TO DO WITH HER 630G. CONTACT PH (B)(6) (EASTERN TIME). THANK YOU!! ALWAYS BY YOUR SIDE, (B)(4), RESOLUTION SPECIALIST, CUSTOMER SUPPORT CENTER MEDTRONIC (B)(4) LET¿S TAKE HEALTHCARE FURTHER, TOGETHER ----END E-MAIL---- (B)(4) SVN (B)(4) INITIAL NOTES: I AM CALLING TO SEE HOW I CAN RETURN THE PUMP NOW THAT MY WIFE HAS PASSED AWAY INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: WIFE PASSED REPORTING PARTY NAME: (B)(6). REPORTING PARTY PHONE: (B)(6). REPORTING PARTY RELATIONSHIP TO DECEASED: HUSBAND. PUMP SERIAL NUMBER: (B)(4). PUMP MATERIAL NUMBER: 630G. GLUCOMETER: ASCENSIA. CGM: MEDTRONIC CGM WAS NOT INCLUDED IN THE PATIENT'S DIABETES THERAPY. DATE OF DEATH: (B)(6) 2017. BG AT TIME OF DEATH: UNKNOWN. CAUSE OF CUSTOMER PASSING AS INDICATED BY REPORTING PARTY: CANCER. LOCATION OF CUSTOMER'S PASSING: HOSPITAL. DATE CUSTOMER WAS ADMITTED TO HOSPITAL/HOSPICE/EMERGENCY ROOM: (B)(6) 2017. BG AT TIME OF CUSTOMER'S ADMISSION TO HOSPITAL/HOSPICE/EMERGENCY ROOM: UNKNOWN. CUSTOMER WAS WEARING PUMP AT TIME OF PASSING. OTHER HEALTH ISSUES: REPORTING PARTY INDICATES OTHER HEALTH ISSUES OR ILLNESS MAY HAVE CONTRIBUTED, OR LED UP, TO PASSING. DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? RESPONSE: NO. DOES REPORTING PARTY KNOW IF CUSTOMER WAS OFF PUMP THERAPY DUE TO OTHER HEALTH ISSUES OR ILLNESS? RESPONSE: STILL ON THE PUMP. PUMP RETURN TO MDT: REPORTING PARTY AGREED TO RETURN THE PUMP. REPORTING PARTY SHIP-TO NAME FOR RETURN MATERIAL SHIPMENT: (B)(6). REPORTING PARTY SHIP-TO ADDRESS FOR RETURN MATERIAL SHIPMENT: (B)(6). CUSTOMER AGREES TO HAVE RETURN LABEL(S) MAILED (3 DAY ARRIVAL) AND RETURN MATERIALS WILL SHIP OVERNIGHT. RETURNING PRODUCT TO BE SHIPPED TO MDT VIA UPS. CARELINK UPLOAD: REPORTING PARTY DID NOT REPORT DKA, HIGH BG, LOW BG, OR ALLEGE UNDER, OR OVER, DELIVERY OF THE PUMP. CARELINK UPLOAD WAS NOT REQUESTED. CUSTOMER WANTS TO RETURN PUMP SINCE HIS WIFE HAS PASSED CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: COMPLETED DEATH REPORT ON CUSTOMER ADDITIONAL NOTES: CUSTOMER'S HUSBAND CALLED IN WANTING TO RETURN THE PUMP NOW THAT HIS WIFE HAS PASSED SHIP: NOTHING / RETURN: NOTHING (B)(6) 2017 18:00:02 PST BATCH USER (BATCH) PHONE(B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756506 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1XZKV 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death