BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12105928 · Received July 2, 2021

    Report

    Report Number
    2032227-2021-163667
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 2, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER BATTERY INSTALLATION, THE UNIT GAVE AN UNEXPECTED FLASHING WHITE / BLANK DISPLAY FOLLOWED BY AN UNEXPECTED INTERMITTENT BEEP ALARM DUE TO MOLD AND CORROSION ON THE LCD CONNECTOR LOCATED ON PCBA2. UNABLE TO PERFORM THE DISPLACEMENT, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS DUE TO THE DISPLAY ANOMALY. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DIED WHEN CUSTOMER WAS SITTING IN SHADE AN ALARM WENT OFF FOLLOWED BY WHITE SCREEN COULD NOT PUSH ANY BUTTONS AND TRIED CHANGING THE BATTERY BUT INSULIN PUMP IS NO LONGER RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009015 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG45JZ8 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR