BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8743450 · Received June 28, 2019

    Report

    Report Number
    2032227-2019-22702
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 21, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO THE CRITICAL PUMP ERROR. UNABLE TO DOWNLOAD DUE TO MOISTURE DAMAGED ON ELECTRONIC ASSEMBLY.

    Description of Event or Problem · 1

    "CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD OPEN BOOK IMAGE AND FAILED BATTERY ALERT." THE BLOOD GLUCOSE LEVEL WAS 141 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY RECEIVED OPEN BOOK IMAGE ON THE SCREEN. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539888 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2VU5Q 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR