BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15039501 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-290220
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    April 29, 2019
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Removal / Correction Number
    Z-0956-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 3.18E. 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 0.08700 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND A CRACKED RETAINER. DATA ANALYSIS: (DATE OF CUSTOMER PASSING: 04/29/19.) (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 65.35. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 64.65. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 66.2. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 69.55. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 74.375. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 60.275. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 37.95. 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 05/03/2019, 14:52:06, MOLLAA1 SEE SVNS (B)(4) FOR RELATED DOCUMENTATION. COMPLAINTS TEXT 05/03/2019, 14:47:24, MOLLAA1 I CONTACTED THE BROTHER/(B)(6) OF THE CUSTOMER A SECOND/FINAL TIME TO FURTHER DISCUSS THE REFERENCED REPORT. I SPOKE WITH (B)(6) WHO STATED THAT HE IS SIMPLY WANTING TO KNOW WHAT PRODUCT MEDTRONIC WILL/WILL NOT ACCEPT BACK ONCE A PERSON PASSES AWAY ((B)(6) DOES NOT HAVE ANY PRODUCT IN HIS POSSESSION AT THE MOMENT/THE HOSPITAL IS IN POSSESSION OF ANY/ALL MEDTRONIC PRODUCT). I EXPLAINED THAT MEDTRONIC ONLY ACCEPTS BACK ANY PRODUCT WORN AT THE TIME OF THE PASSING/INCIDENT (I.E. THE PUMP, RESERVOIR IN-USE, INFUSION SET IN-USE AND THE SENSOR IN-USE). COMPLAINTS TEXT 05/03/2019, 09:48:09, MOLLAA1 I CONTACTED THE BROTHER/(B)(6) OF THE CUSTOMER (TO FURTHER DISCUSS THE REFERENCED REPORT) BUT NO ONE ANSWERED/THE VOICEMAIL BOX HAD NOT BEEN SETUP SO NO CONTACT COULD BE COMPLETED. THE 24-HOUR TECHNICAL SUPPORT SOLUTIONS TEAM WILL MAKE AN ADDITIONAL ATTEMPT TO CONTACT (B)(6) AT A LATER TIME. COMPLAINTS TEXT 05/03/2019, 09:43:15 , MOLLAA1 I MARKED THE ACCOUNT INACTIVE/DECEASED (WHILE OPTING OUT OF ALL COMMUNICATIONS) AS WELL AS VOIDED THE MEDTRONIC DEVICE/PUMP WARRANTY. COMPLAINTS TEXT 05/02/2019 10:33:29 ARIASL10 CUST BROTHER WOULD LIKE A CALL BACK TO SEE WHAT HE NEEDS TO DO WITH THE DEVICES. COMPLAINTS TEXT 05/02/2019 10:30:37 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 05/02/2019 10:23:49 ARIASL10 INITIAL NOTES: MY BRO HAD ONE OF YOUR PUMP AND HE PASSED AWAY AND DON'T KNOW WHAT TO DO WITH IT. (B)(6)- BROTHER MMT-7020A LOT- HG36B2B MMT- 332A LOT- HG39585 MMT-399 LOT- 6203437 INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: TRYING TO REPORT MY BROTHERS DEATH DECEASED REPORTING PER DOP114-980. 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: BROTHER . REPORTING PARTY IS AWARE OF THE DECEASED EVENT DETAILS. DATE OF CUSTOMER PASSING: (B)(6) 2019. CAUSE OF CUSTOMER PASSING AS INDICATED BY REPORTING PARTY: HEART STOPPED . LOCATION OF CUSTOMER¿S PASSING: HOSPITAL . DATE CUSTOMER WAS ADMITTED TO HOSPITAL, EMERGENCY ROOM OR HOSPICE (IF KNOWN): (B)(6) 2019 . BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM, (IF KNOWN): 200. DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? THYROID AND HIGH BLOOD PRESSURE . DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIME FRAME OF HEALTH ISSUE OR ILLNESS? JUST THAT HIS HEART STOPPED . WAS PUMP WORN AT THE TIME OF PASSING? YES. PUMP MATERIAL NUMBER: PUMP MMT-1780KPK 670G BLACK MG. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-399. INFUSION SET LOT/BATCH: 6203437. RESERVOIR MATERIAL NUMBER: 332A. RESERVOIR LOT/BATCH: HG39585. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): KIT MMT-1152US METER ADC NXTLK MG NSBL. BG-1540409B IT WAS ON HIS FILE USING THAT ONE. THEY COULDN'T PROVIDE ME THE SERIAL NUMBER NOR THE BRAND FOR THE METER WAS MEDTRONIC CGM INCLUDED IN DIABETES THERAPY? YES. WAS CGM WORN AT TIME OF EVENT? REPORTING PARTY IS UNSURE. TRANSMITTER MATERIAL NUMBER: MMT-7811NA . TRANSMITTER SERIAL NUMBER: (B)(4). SENSOR MATERIAL NUMBER: MMT-7020A. SENSOR LOT/BATCH: HG36B2B. THIS INFO WAS TAKEN FROM THE ACCOUNT- CUST BROTHER WAS UNABLE CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: CUST WANTED TO SEE WHAT I CAN DO WITH THE SUPPLIES AND DEVICES SHIP: NOTHING /RETURN: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897900 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG236MD 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Death