BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 15028489 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287961
    Event Type
    Death
    Date Received
    July 15, 2022
    Date of Event
    April 2, 2020
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000187422
    Removal / Correction Number
    Z-0956-2020
    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-0956-2020. (B)(4). S/W 4.11J. UNIT RECEIVED WITH A DEFIANT 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 0.08720 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, STAINED 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) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 64.525. (B)(6) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 45.1. (B)(6) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 43.1. (B)(6) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 47.1. (B)(6) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 53.775. (B)(6) 2020: DAILY TOTAL OF ALL INSULIN DELIVERED = 21.15. (B)(6) 2020: 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

    (B)(6) 2020, 21:49:41 PST, ICE BATCH USER (BATCH_ICE), PHONE (B)(6), COMPLAINT: (B)(4), COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6), TAKEN BY: (B)(6), (B)(6) 2020, 3:40 PM, (B)(6): REF PUMP (B)(4), REF INFUSION SET (B)(4), REF RESERVOIR (B)(4), REF SENSOR (B)(4), INITIAL NOTES: HEART DISEASE FIRST CAUSE AND DIABETES SECOND CAUSE OF DEATH INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: HUSBAND WAS TRANSFERRED BY (B)(6) FROM CUSTOMER SERVICE TO REPORT A DEAD NOTIFICATION OF HIS WIFE. HUSBAND SAYS FIRST CAUSE OF DEAD IS HEART DISEASE AND THE SECOND CAUSE IS DIABETES DECEASED REPORTING PER (B)(6). FIRST AND LAST NAME OF PERSON REPORTING EVENT: (B)(6). BEST PHONE NUMBER TO REACH PERSON REPORTING EVENT: (B)(6). RELATIONSHIP OF PERSON REPORTING EVENT TO THE DECEASED: HUSBAND. REPORTING PARTY IS AWARE OF THE DECEASED EVENT DETAILS. DATE OF CUSTOMER PASSING: (B)(6) 2020. CAUSE OF CUSTOMER PASSING AS INDICATED BY REPORTING PARTY: HEART DISEASE AND DIABETES. LOCATION OF CUSTOMER¿S PASSING: HOME. DATE CUSTOMER WAS ADMITTED TO HOSPITAL, EMERGENCY ROOM OR HOSPICE (IF KNOWN): N/A. BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM, (IF KNOWN): N/A. DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? NONE. DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? CUSTOMER IS NOT AWARE OF THE PRECISE DATE BUT HE SAYS HIS WIFE HAS HAD BOTH CONDITIONS FOR A MANY YEARS NOW. WAS PUMP WORN AT THE TIME OF PASSING? YES. PUMP MATERIAL NUMBER: MMT-1762KCN. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-242600. INFUSION SET LOT/BATCH: 5296384. RESERVOIR MATERIAL NUMBER: MMT-332A. RESERVOIR LOT/BATCH: HG3NGZ7. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): CONTOUR NEXTLINK 2.4. WAS MEDTRONIC CGM INCLUDED IN DIABETES THERAPY? YES. WAS CGM WORN AT TIME OF EVENT? YES. TRANSMITTER MATERIAL NUMBER: HUSBAND DID NOT HAVE THE TRANSMITTER NOR THE BOX IT CAME FROM. TRANSMITTER SERIAL NUMBER: HUSBAND DID NOT HAVE THE TRANSMITTER NOR THE BOX IT CAME FROM. SENSOR MATERIAL NUMBER: MMT-7020. SENSOR LOT/BATCH: CUSTOMER COULD NOT FIND IT. REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD. REASON REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD: CUSTOMER SAYS HE IS NOT COMPUTER LITERATE, . DOES NOT LIKE USING COMPUTERS I OFFERED TO ASSIST REMOTELY BUT HE DIDN'T WANT TO. 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. HUSBAND SAYS HE DOESN'T NEED THE PUMP BACK NAME FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). ADDRESS FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). PHONE NUMBER FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: I WAS ABLE TO OBTAIN SOME INFORMATION FROM CUSTOMER BUT HE DID NOT WANT TO UPLOAD THE PUMP TO CARELINK. HE MENTIONED HE HARDLY USES COMPUTERS. CUSTOMER ALSO AGREED TO SEND US THE PUMP AND I WILL BE SENDING A RETURN LABEL AND A CANNISTER FOR HIM TO SEND US BACK THE PUMP SINCE HE SAID HE DOESN'T HAVE A PUMP AND HE MIGHT HAVE TO COMBINED IT WITH THE OTHER BOXES HE IS SENDING TO CUSTOMER SERVICE. CUSTOMER COULD NOT FIND THE TRANSMITTER TO PROVIDE ME WITH THE SERIAL NUMBER OF THE TRANSMITTER WHICH WAS IN USE AS SUCH REASON WHY A PO IS NOT CREATED UNDER TRANSMITTER SINCE I DO NOT KNOW WHICH ONE WAS IN USE. SHIP: RETLAB, CANNISTER / RETURN: NOTHING WARRANTY REPLACEMENT (B)(4), COUNTRY: CANADA, CITY: (B)(4), ZIP: (B)(4), INPUT DATE: (B)(6) 2020, WARRANTY START: (B)(6) 2019, WARRANTY END: (B)(6) 2023, BATCH - NG1799426H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371848 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K 00763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death