BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 15039745 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-289745
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    June 26, 2020
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000173036
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. RECALL: Z-0955-2020. (B)(4). S/W 4.10C. 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 SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: 06/20/2020 DAILYTOTALOFALLINSULINDELIVERED = 1.4. 06/21/2020 DAILYTOTALOFALLINSULINDELIVERED = 10.95. 06/22/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.3. 06/23/2020 DAILYTOTALOFALLINSULINDELIVERED = 11.675. 06/24/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.2. 06/25/2020 DAILYTOTALOFALLINSULINDELIVERED = 0. 06/26/2020 DAILYTOTALOFALLINSULINDELIVERED = 0.

    Description of Event or Problem · 0

    COMPLAINTS TEXT 07/14/2020 13:42:58 DIAZL76 TRACKING NUMBER: (B)(4). SERVICE: UPS NEXT DAY AIRLABEL DELIVERY METHOD: 3 UPS PICKUP ATTEMPTS. COMPLAINTS TEXT 06/27/2020 07:35:31 MATTEC3 I MARKED THE ACCOUNT INACTIVE/DECEASED (WHILE OPTING OUT OF ALL COMMUNICATIONS) AS WELL AS VOIDED THE MEDTRONIC DEVICE/PUMP WARRANTY. WARRANTY END DATE WILL REFLECT (B)(6) 2020 DATE OF CUST PASSING PER REPORT. COMPLAINTS TEXT 06/26/2020 12:50:24 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 06/26/2020 12:40:28 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 06/26/2020 12:39:34 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT 06/26/2020 12:34:12 SIAPNA2 INITIAL NOTES: CUST STATED THAT SHE IS CALLING TO CHECK ON HOW TO SEND THE PUMP BACK INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: PT PASSED AWAY DECEASED REPORTING PER (B)(4). WHAT LED UP TO EVENT: CHRONIC RESPIRATORY PROBLEM . 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: SPOUSE . 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: CHRONIC RESPIRATORY PROBLEM . LOCATION OF CUSTOMER¿S PASSING: HOSPICE . DATE CUSTOMER WAS ADMITTED TO HOSPITAL, EMERGENCY ROOM OR HOSPICE (IF KNOWN): HOSPICE . BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM, (IF KNOWN): NOT AVAILABLE . DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? CHRONIC RESPIRATORY PROBLEM . DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? LUNG PROBLEM . WAS PUMP WORN AT THE TIME OF PASSING? YES. PUMP MATERIAL NUMBER: MMT-1715KR. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-397. INFUSION SET LOT/BATCH: 5070157. RESERVOIR MATERIAL NUMBER: MMT-332A. RESERVOIR LOT/BATCH: HG04S4G. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): NA . CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: COMPLETED DEATH REPORT FORM SHIP: NOTHING / RETURN: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112225 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG3AF2T 00763000173036

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Death