BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15039359 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-289088
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    August 31, 2020
    Report Date
    July 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    Removal / Correction Number
    Z-0958-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. Z-0958-2020 (B)(4). S/W 3.18E. UNIT RECEIVED WITH A DEPLETED DURACELL 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 0.08715 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL, 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 DAILYTOTALOFALLINSULINDELIVERED = 32.35, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 26.675, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 0, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 0, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 0, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 0, (B)(6) 2020 DAILYTOTALOFALLINSULINDELIVERED = 0. 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

    CUSTOMER'S WIFE REPORTED THAT HER HUSBAND PASSED ON (B)(6) 2020. THE CAUSE OF DEATH WAS UNKNOWN. THE BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS UNKNOWN. THE CUSTOMER WAS OFF FROM INSULIN PUMP FOR 4 DAYS PRIOR TO PASSING. THE INSULIN PUMP WAS LAST WORN ON (B)(6) 2022. THE INSULIN PUMP WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896667 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2HMAA 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death