BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 9966605 · Received April 16, 2020

    Report

    Report Number
    2032227-2020-104293
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    April 11, 2020
    Report Date
    June 16, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELFTEST. DEVICE RECEIVED WITH THE AUDIO ALERT FUNCTIONING PROPERLY. NO AUDIO ALERT ANOMALY NOTED. PUMP ERROR 63 (VARIABLE 3) WAS CONFIRMED IN THE DEVICE HISTORY DUE TO BROKEN PIN 6 TRACE (SDA) ON U1 KEYPAD ASSEMBLY.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELFTEST. DEVICE RECEIVED WITH THE AUDIO ALERT FUNCTIONING PROPERLY. NO AUDIO ALERT ANOMALY NOTED. PUMP ERROR 63 (VARIABLE 3) WAS CONFIRMED IN THE DEVICE HISTORY DUE TO BROKEN PIN 6 TRACE (SDA) ON U1 KEYPAD ASSEMBLY.

    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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE FAILED THE AUDIO TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432569 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2GXX9 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR