BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15037820 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288588
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    January 22, 2020
    Report Date
    July 17, 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
    VA, 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. DEVICE RECEIVED WITH A DEPLETED ENERGIZER ULTIMATE LITHIUM BATTERY INSTALLED. DEVICE 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 DELIVERY ACCURACY TEST AT 0.08720 INCHES. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, 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: 01/16/2020 DAILYTOTALOFALLINSULINDELIVERED = 37.5. 01/17/2020 DAILYTOTALOFALLINSULINDELIVERED = 34.5. 01/18/2020 DAILYTOTALOFALLINSULINDELIVERED = 35.5. 01/19/2020 DAILYTOTALOFALLINSULINDELIVERED = 32.6. 01/20/2020 DAILYTOTALOFALLINSULINDELIVERED = 33.5. 01/21/2020 DAILYTOTALOFALLINSULINDELIVERED = 55.45. 01/22/2020 DAILYTOTALOFALLINSULINDELIVERED = 28.5.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS AN OVER DOSE, POSSIBLY ALCOHOL RELATED, BUT WAS UNCONFIRMED BY THE CONCLUSION OF THE AUTOPSY. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE AUTO MODE ON THE INSULIN PUMP WAS NOT ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. THE INSULIN PUMP HAD BEEN DISCONNECTED WITHIN AN UNKNOWN TIME PERIOD PRIOR TO PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER STATED THE CUSTOMER'S PUMP WAS FOUND INSIDE THE CUSTOMER'S POCKET AND THE INFUSION SET WAS NOT INSERTED IN THE CUSTOMER'S BODY. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. PUMP PASSED THE FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892670 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2SX9V 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Death