BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15037852 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-289409
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    March 27, 2020
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Removal / Correction Number
    Z-0956-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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-0956-2020. (B)(4). S/W 4.11E. 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 0.08730 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: 03/21/2020 DAILYTOTALOFALLINSULINDELIVERED = 9.55. 03/22/2020 DAILYTOTALOFALLINSULINDELIVERED = 13.85. 03/23/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.35. 03/24/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.35. 03/25/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.35. 03/26/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.35. 03/27/2020 DAILYTOTALOFALLINSULINDELIVERED = 6.35.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2020. THE CAUSE OF DEATH STAGE 4 CANCER. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. INSULIN PUMP WAS RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2893798 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2XB1V 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Death FRN-UNK-RSVR, UNOMED SET