BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15039557 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288287
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    July 12, 2020
    Report Date
    July 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Removal / Correction Number
    Z-0956-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. CORRECTION/REMOVAL NUMBER: Z-0956-2020. (B)(4). S/W 4.11E. UNIT RECEIVED WITH PROCELL ALKALINE BATTERY INSTALLED. 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 0.08710 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 6.625. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 16.1. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 6.775. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 0. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 0. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 0. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 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

    COMPLAINTS TEXT 07/20/2020, 05:48:17, MATTEC3 UPDATED REPORTED BY INFO TO REFLECT WIFE (B)(6) NAME. COMPLAINTS TEXT 07/20/2020, 05:46:22, MATTEC3 SEE SVNS (B)(4) FOR ORIGINAL GFE. COMPLAINTS TEXT 07/19/2020, 07:20:06, ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 07/19/2020, 07:17:37, ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 07/19/2020, 07:17:34, ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 07/19/2020, 07:17:28, VEGAR21 ADDITIONAL-(B)(6) PLEASE CALL THIS NUMBER TO GET ANY INFORMATION ABOUT MR. (B)(6). THIS IS WIFE NUMBER. COMPLAINTS TEXT 07/19/2020, 07:15:52, VEGAR21 INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUST TRYING TO LET MDT KNOW HUSBAND PASSED. DECEASED REPORTING PER DOP114-980. WHAT LED UP TO EVENT: HE HAD A STROKE. FIRST AND LAST NAME OF PERSON REPORTING EVENT: (B)(6)/WIFE. BEST PHONE NUMBER TO REACH PERSON REPORTING EVENT: (B)(6). RELATIONSHIP OF PERSON REPORTING EVENT TO THE DECEASED: WIFE. REPORTING PARTY IS AWARE OF THE DECEASED EVENT DETAILS. DATE OF CUSTOMER PASSING: 7/12. CAUSE OF CUSTOMER PASSING AS INDICATED BY REPORTING PARTY: STROKE. LOCATION OF CUSTOMER¿S PASSING: CUST WAS IN THE HOSPITAL. DATE CUSTOMER WAS ADMITTED TO HOSPITAL, EMERGENCY ROOM OR HOSPICE (IF KNOWN): ADMITTED. BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM, (IF KNOWN): 168. DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? NO. DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? NO. WAS PUMP WORN AT THE TIME OF PASSING? YES. PUMP MATERIAL NUMBER: MMT-1780KPK . PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: 5294690. INFUSION SET LOT/BATCH: MMT-397. RESERVOIR MATERIAL NUMBER: MMT-332A. RESERVOIR LOT/BATCH: HG41RYB. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): ASCENSIA. WAS MEDTRONIC CGM INCLUDED IN DIABETES THERAPY? NO. DEXTCOME REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD. REASON REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD: N/A, SAYS AN UPLOAD HAPPENNED COUPLE WEEKS AGO.. REQUESTED RETURN OF MDT SYSTEM IN USE AT TIME OF DECEASED EVENT. ADV PUMP WILL UNDERGO DESTRUCTIVE TESTING AND PRODUCT CANNOT BE RETURNED. CALLER AGREED TO RETURN PRODUCT. NAME FOR SHIPMENT OF PRODUCT RETURN MATERIALS: PUMP, SETS AND RESERVOIR. ADDRESS FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). PHONE NUMBER FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). EXPLAINED RETURN INSTRUCTIONS. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: SUBMITTED SHIP: NOTHING / RETURN: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960345 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG31XS9 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Death