BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 15038855 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-290245
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    December 16, 2019
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. 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 01/06/2020 13:09:30 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 01/06/2020 13:06:44 MATTEC3 I MARKED THE ACCOUNT INACTIVE/DECEASED (WHILE OPTING OUT OF ALL COMMUNICATIONS) AS WELL AS VOIDED THE MEDTRONIC DEVICE/PUMP WARRANTY. (B)(6) 2019 IS END DATE. COMPLAINTS TEXT 01/06/2020 13:01:33 MATTEC3 CORRECTING INC DATE TO REFLECT (B)(6) 2019-DOD AND ADDED SVN ON MMT-397 TO COMPLETE SYSTEM REGISTRATION. CREATING ZRCI AND ZRSC ORDERS TO BRING BACK PRODUCTS. COMPLAINTS TEXT 01/03/2020 21:15:19 SALERO2 OUTBOUND CALL TO KY WAREHOUSE AND SPOKE WITH (B)(6). REQUESTED TO DELETE OUTBOUND DELIVERY FOR 5900819594 & 5900819596 AS INSTRUCTED BY (B)(6). COMPLAINTS TEXT 01/03/2020 17:51:09 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 01/03/2020 17:51:06 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 01/03/2020 17:50:59 SULTAM5 CALLER SAID THAT THE WERE USING THE PUMP WHEN CUSTOMER PASSED AWAY BUT THEY CONFIRMED THAT IT WAS NOT CAUSED BY OUR PRODUCT. COMPLAINTS TEXT 01/03/2020 17:35:42 SULTAM5 INITIAL NOTES: THE DAUGHTER OF THE CUSTOMER CALLED IN TO REPORT THAT HER MOTHER WHICH IS THE ACCOUNT HOLDER DIED AND NEED TO KNOW WHAT SHE NEEDS TO DO WITH THE PUMP. INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: WILLING TO RETURN THE PUMP BACK TO MEDTRONIC. 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: DAUGHTER OF (B)(6). 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 RELATED ISSUE. LOCATION OF CUSTOMER¿S PASSING: HOME(BUT WAS UNDER HOSPICE CARE AT (B)(6) HEALTHCARE. 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): 101MG/DL-104MG/DL. DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? KIDNEY FAILURE AND MULTIPLE ISSUES WITH DIABETES, PULMONARY DISEASE. DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? YEARS AGO AND CAN NO LONGER RECALL. WAS PUMP WORN AT THE TIME OF PASSING? YES. PUMP MATERIAL NUMBER: MMT-1715K 630G 3ML BLACK. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: CALLER DOES NOT HAVE THE INFORMATION. INFUSION SET LOT/BATCH: CALLER DOES NOT HAVE THE INFORMATION. RESERVOIR MATERIAL NUMBER: CALLER DOES NOT HAVE THE INFORMATION. RESERVOIR LOT/BATCH: CALLER DOES NOT HAVE THE INFORMATION. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): CALLER DOES NOT HAVE THE INFORMATION. WAS MEDTRONIC CGM INCLUDED IN DIABETES THERAPY? NO. USED DEXCOM HEART DISEASE REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD. REASON REPORTING PARTY IS UNABLE TO COMPLETE CARELINK UPLOAD: CALLER DOES NOT HAVE THE INFORMATION. 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, RESERVOIR AND INFUSION SET. ADDRESS FOR SHIPMENT OF PRODUCT RETURN MATERIALS: (B)(6). PHONE NUMBER FOR SHIPMENT OF PRODUCT RETURN MATERIALS: 6023302305. (B)(6) EXPLAINED RETURN INSTRUCTIONS. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: COLLECTED CONTACT INFORMATION FOR DECEASED REPORTING. SHIP: NOTHING / RETURN: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945135 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2GXZH 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Death