BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8925060 · Received August 23, 2019

    Report

    Report Number
    2032227-2019-52096
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. ALSO, PUMP RECEIVED WITH MOISTURE DAMAGE ON THE BATTERY TUBE, MOTOR, VIBRATOR AND KEYPAD ASSEMBLY NOTED. UNABLE TO PERFORM THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST DUE TO BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY DO HEAR FLUID WHEN SHAKING THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 146 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY SEE FLUID UNDER THE LCD. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719334 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 13 YR