BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15011486 · Received July 14, 2022

    Report

    Report Number
    2032227-2022-285147
    Event Type
    Death
    Date Received
    July 14, 2022
    Date of Event
    September 26, 2020
    Report Date
    July 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000643169939219
    Removal / Correction Number
    Z-0956-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. H9: Z-0956-2020. (B)(4). S/W 3.18E. UNIT RECEIVED WITH A DEPLETED ENERGIZER 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 0.08715 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: 09/20/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 46.125, 09/21/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 52.825, 09/22/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 47.475, 09/23/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 43.925, 09/24/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 45.675, 09/25/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 51.575, 09/26/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 32.05.

    Description of Event or Problem · 0

    SVN: (B)(4). 1. START DATE OF THE SENSOR: 2. START HOUR OF THE SENSOR: 3. SENSOR START MISSING REASON: DOES NOT KNOW 4. LOCATION OF SENSOR INSERTION: DOES NOT KNOW 5. DATE OF SENSOR ALERT: 6. HOUR OF SENSOR ALERT: 7. SENSOR ALERT MISSING REASON: DOES NOT KNOW COMPLAINTS TEXT 10/13/2020 08:40:11 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 10/13/2020 08:31:07 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 10/13/2020 08:27:29 MOLLAA1 SEE S/O TRANSACTIONS (B)(4) (TRANSMITTER) AND (B)(4) (PUMP) AND THE UPS CAMPUS SHIP RETURN REQUEST FOR THE RETURN OF THE DEVICES TO MEDTRONIC. TRACKING NUMBER: (B)(4). SERVICE: UPS NEXT DAY AIR LABEL DELIVERY METHOD: PRINT AND MAIL RETURN LABEL PUMP RETURN REQUEST: (B)(6), IN (B)(4) COMPLAINTS TEXT 10/13/2020 08:19:41 MOLLAA1 I MARKED THE ACCOUNT INACTIVE/DECEASED (WHILE OPTING OUT OF ALL COMMUNICATIONS) AS WELL AS VOIDED THE MEDTRONIC DEVICE WARRANTY. SVNS CORRECTED TO REFLECT THE PROPER REPORTED BY TYPE, THE PROPER BG MISSING REASON, THE PROPER WEIGHT AND THE PROPER HARM/TREATMENT CODE(S). SVNS (B)(4) CREATED IN ERROR TO REPORT THE SAME EVENT SO THE SVNS WERE DELETED/THE NOTATIONS ARE BEING COPIED INTO THE ORIGINAL REPORT TO PROVIDE ADDITIONAL DETAILS PERTAINING TO THE SAME INCIDENT: COMPLAINTS TEXT 10/12/2020 10:23:07 ALONZR2 CUSTOMER CONCERN: MY HUSBAND PASSED AWAY COUPLE WEEKS AGO, HE GOT HIS SUPPLY TO MEDTRONIC. (B)(4): DECEASED REPORTING WHAT LED UP TO THE EVENT?: DECEASED DOCUMENT FIRST AND LAST NAME OF PERSON REPORTING EVENT: (B)(6) DOCUMENT BEST PHONE NUMBER TO REACH PERSON REPORTING EVENT: (B)(4) DOCUMENT RELATIONSHIP OF PERSON REPORTING EVENT TO THE DECEASED: WIFE IS REPORTING PARTY AWARE OF THE DECEASED EVENT DETAILS?: YES EXPLAIN WE WILL GATHER THE DETAILS TO THE EXTENT AVAILABLE TO THE PERSON REPORTING. DATE OF CUSTOMER PASSING: (B)(6): CAUSE OF CUSTOMER PASSING: COMPLICATIONS DUE TO DIABETES, HEART GAVE OUT INDICATE THE LOCATION OF CUSTOMER¿S PASSING. (E.G. OCCURRED AT HOME, HOSPITAL, EMERGENCY ROOM, HOSPICE ETC.): OCCURRED AT HOME DATE CUSTOMER WAS ADMITTED TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM REASON FOR ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM: N/A BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM. DOES NOT KNOW MG/DL DOCUMENT ANY HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING: COMPLICATIONS DUE TO DIABETES, HEART GAVE OUT WAS PUMP WORN AT TIME OF PASSING?: YES OBTAIN MEDTRONIC INSULIN PUMP DELIVERY SYSTEM COMPONENTS WORN OR USED AT TIME OF EVENT PUMP MATERIAL NUMBER: PUMP MMT-1780KPK 670G BLACK MG PUMP SERIAL NUMBER: (B)(4) INFUSION SET MATERIAL NUMBER: MMT-332A INFUSION SET LOT/BATCH: DOES NOT KNOW RESERVOIR MATERIAL NUMBER: MMT-386 RESERVOIR LOT/BATCH: DOES NOT KNOW NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): MMT-1152US WAS CUSTOMER USING A SENSOR?: YES WAS A SENSOR WORN AT TIME OF EVENT?: YES OBTAIN CGM SYSTEM COMPONENTS WORN OR USED AT TIME OF EVENT TRANSMITTER MATERIAL NUMBER: MMT-7811NA TRANSMITTER SERIAL NUMBER: (B)(4). SENSOR MATERIAL NUMBER: MMT-7020A SENSOR LOT/BATCH: HG4BE09 CAN REPORTING PARTY COMPLETE CARELINK UPLOAD?: NO DOCUMENT REASON REPORTING PARTY IS UNABLE TO PERFORM/COMPLETE CARELINK UPLOAD; E.G. NO COMPUTER AVAILABLE, NO LINK/USB DEVICE AVAILABLE, ETC: DOES NOT HAVE A COMPUTER AVAILABLE REQUEST THE RETURN OF THE MDT SYSTEM IN USE AT THE TIME OF THE DECEASED EVENT. ADVISE CALLER PUMP WILL UNDERGO DESTRUCTIVE TESTING AND PRODUCT CANNOT BE RETURNED. DOES CALLER AGREE TO RETURN PRODUCT?: YES DOES REPORTER SPECIFICALLY REQUEST THAT THE PUMP BE RETURNED TO THEM AFTER ANALYSIS?: YES ADVISE THAT AN EFFORT WILL BE MADE TO RETURN THE PUMP HOWEVER DESTRUCTIVE TESTING MAY BE CONDUCTED AND THE PUMP WILL BE RENDERED NON -FUNCTIONAL AND WOULD NOT BE CERTIFIED BY MEDTRONIC FOR USE ON ANOTHER PATIENT. OBTAIN REPORTING PARTY¿S NAME, ADDRESS, AND PHONE NUMBER. NAME OF SHIP TO PARTY FOR RETURN: (B)(6) SHIPPING ADDRESS FOR RETURN: (B)(6). TELEPHONE NUMBER OF THE SHIP TO PARTY FOR RETURN: (B)(6). DOES CALLER SPECIFICALLY REPORT CUSTOMER HAD OTHER PUMPS THAT WERE BEING STORED AND NOT USED THAT THEY WOULD ALSO LIKE TO RETURN?: NO DOES CALLER SPECIFICALLY REQUEST A FAILURE ANALYSIS LETTER?: NO DOCUMENT NAME FOR SHIPMENT OF PRODUCT RETURN MATERIALS: PUMP, METER, SENSORS, INFUSION SETS AND RESERVOIRS DOCUMENT ADDRESS FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). DOCUMENT PHONE NUMBER FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(4) PROVIDE CUSTOMER RETURN INSTRUCTIONS PER LOCAL GUIDELINES. ***NOTATION CLARIFICATION*** CONFIRMED THE CUSTOMER WAS WEARING THE MEDTRONIC CGMS/SENSOR AT THE TIME OF THE REPORTED INCIDENT. WAS CUSTOMER USING A SENSOR?: YES WAS A SENSOR WORN AT TIME OF EVENT?: YES TRANSMITTER MATERIAL NUMBER: MMT-7811NA TRANSMITTER SERIAL NUMBER: (B)(4) SENSOR MATERIAL NUMBER: MMT-7020A SENSOR LOT/BATCH: HG4BE09 CONFIRMED THE SPOUSE DID NOT RECALL THE BG OF THE CUSTOMER AT THE TIME OF THE INCIDENT. BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM. DOES NOT KNOW MG/DL ADDITIONAL SVNS CREATED (UNDER THE TRANSMITTER AND SENSOR) TO PROPERLY DOCUMENT THE REFERENCED REPORT. COMPLAINTS TEXT 10/05/2020 11:20:09 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 10/05/2020 11:19:32 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 10/05/2020 11:19:29 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 10/05/2020 11:13:51 PANTER2 CUSTOMER CONCERN: PT'S WIFE CALLED IN TELLING THAT HIS HUSBAND PASSED AWAY A WEEK AGO AND SHE LIKE TO KNOW WHAT SHE NEEDED TO DO ON THE PUMP AND OTHER SUPPLIES THAT SHE STILL HAD. PT'S WIFE SAID THERE ARE SOME SUPPLIES THAT ARE STILL UNOPEN AS WELL. DOP114-980DOC: DECEASED REPORTING WHAT LED UP TO THE EVENT?: NO IDEA DOCUMENT FIRST AND LAST NAME OF PERSON REPORTING EVENT: (B)(6) DOCUMENT BEST PHONE NUMBER TO REACH PERSON REPORTING EVENT: (B)(4) DOCUMENT RELATIONSHIP OF PERSON REPORTING EVENT TO THE DECEASED: WIFE IS REPORTING PARTY AWARE OF THE DECEASED EVENT DETAILS?: YES EXPLAIN WE WILL GATHER THE DETAILS TO THE EXTENT AVAILABLE TO THE PERSON REPORTING. DATE OF CUSTOMER PASSING: (B)(6) 2020: CAUSE OF CUSTOMER PASSING: HEART FAILURE / HEART STOP INDICATE THE LOCATION OF CUSTOMER¿S PASSING. (E.G. OCCURRED AT HOME, HOSPITAL, EMERGENCY ROOM, HOSPICE ETC.): HOME DATE CUSTOMER WAS ADMITTED TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM REASON FOR ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM: N/A BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM. 200 MG/DL DOCUMENT ANY HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING: HEART FAILURE / STAGE 4 KIDNEY FAILURE DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS?: STAGE 4 KIDNEY FAILURE, 3 YRS AGO BUT LONG TIME KIDNEY FAILURE DIABETES, PT WAS (B)(6) HEART ATTACK / STROKE, AT (B)(6) WAS PUMP WORN AT TIME OF PASSING?: YES OBTAIN MEDTRONIC INSULIN PUMP DELIVERY SYSTEM COMPONENTS WORN OR USED AT TIME OF EVENT PUMP MATERIAL NUMBER: MMT-1780KPK PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-386 INFUSION SET LOT/BATCH: 5233380 RESERVOIR MATERIAL NUMBER: MMT-332A RESERVOIR LOT/BATCH: HG38FPG NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): ASCENSIA WAS CUSTOMER USING A SENSOR?: YES WAS A SENSOR WORN AT TIME OF EVENT?: NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061990 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG29SE4 000000643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Death