BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12223467 · Received July 26, 2021

    Report

    Report Number
    2032227-2021-171851
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 25, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNIT PASSED DISPLACEMENT TEST AND SELF-TEST. HARDWARE LOW LEVEL FAILURES (VARIABLE 3) WAS PRESENT IN THE INSULIN PUMP TRACE DOWNLOAD DUE TO BROKEN TRACE AT PIN 6 (SDA), CRACKED SOLDER JOINT AT PIN 6 (SDA) ON KEYPAD ASSEMBLY. TOGGLED ON, OFF AND INCREASED, DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURES ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER STATED THAT THEY PERFORMED SELF TEST. INSULIN PUMP PASSED SELF TEST. CUSTOMER WAS ASSISTED WITH AUTO MODE FEATURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120203 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3C7PE 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR