BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 15026721 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287728
    Event Type
    Death
    Date Received
    July 15, 2022
    Date of Event
    November 9, 2020
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000190439
    Removal / Correction Number
    H9: Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-0955-2020. (B)(4). S/W 4.11C. INSULIN PUMP RECEIVED WITH A ENERGIZER ALKALINE BATTERY INSTALLED. INSULIN PUMP 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 0.0875 INCHES. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. INSULIN PUMP UPLOADED PROPERLY USING CARELINK. INSULIN PUMP HAD SCRATCHED CASE, CRACKED CASE AT THE CORNER OF THE BELT CLIP RAIL, 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 = 38.65, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 35, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 23.4, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 30.3, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 25.45, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 19, (B)(6) 2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 0.

    Description of Event or Problem · 0

    COMPLAINTS TEXT: (B)(6) 2020 10:09:08 MAINL1 CORRECTED SALES ORCER TYPE AS NEXT OF KIN IS SENDING PUMP BACK TO MEDTRONIC. COMPLAINTS TEXT (B)(6) 2020 10:10:06 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT (B)(6) 2020 10:09:33 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT (B)(6) 2020 10:09:07 FLAMEV1 I MARKED THE ACCOUNT INACTIVE/DECEASED AS WELL OPTED OUT OF MARKETING/ACCOUNT COMM. PREF. UPDATED DEVICE WARRANTY AS NEEDED. COMPLAINTS TEXT (B)(6) 2020 10:07:00 FLAMEV1 CREATED ADDITIONAL SVNS FOR RESERVOIR AND INFUSION SET, UPDATED WEIGHT FIELD TO UNKNOWN, CORRECTED INCIDENT DATE TO REFECT DATE PATIENT REPORTEDLY PASSED AWAY (B)(6) 2020. COMPLAINTS TEXT (B)(6) 2020 09:07:38 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT (B)(6) 2020 08:58:50 (B)(6) CUSTOMER CONCERN: (B)(6). CUSTOMERS HUSBAND STATES HIS WIFE PASED AWAY ON (B)(6). DOC: DECEASED REPORTING WHAT LED UP TO THE EVENT?: UNKNOWN ON THE CAUSE OF DEATH. 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: HUSBAND 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 STOPPED. INDICATE THE LOCATION OF CUSTOMER¿S PASSING. (E.G. OCCURRED AT HOME, HOSPITAL, EMERGENCY ROOM, HOSPICE ETC.): HOSPITAL. (B)(6). DATE CUSTOMER WAS ADMITTED TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM: (B)(6) 2020 REASON FOR ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM: HOSPITAL. BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM: UNKNOWN MG/DL DOCUMENT ANY HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING: UNKNOWN DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS?: UNKNOWN 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-1755K. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-397. INFUSION SET LOT/BATCH: 5313309. RESERVOIR MATERIAL NUMBER: MMT-332A. RESERVOIR LOT/BATCH: HG4C2CG. NAME OF GLUCOMETER BEING WORN OR USED (ASCENSIA, LIFESCAN, ETC.): BG1755558B. WAS CUSTOMER USING A SENSOR?: NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047591 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG34FHA 000000763000190439

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death