BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 9956509 · Received April 14, 2020

    Report

    Report Number
    2032227-2020-102748
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    December 8, 2019
    Report Date
    June 15, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST. DEVICE RECEIVED WITH SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1, PUMP ERROR 63 (VARIABLE 3) WAS PRESENT IN THE DEVICE TRACE DOWNLOAD AND PUMP ERROR 63 (VARIABLE 3) ALARMED DURING SELFTEST DUE TO BROKEN TRACE AT U1 PIN 6 (SDA) ON KEYPAD ASSEMBLY.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST. DEVICE RECEIVED WITH SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1, PUMP ERROR 63 (VARIABLE 3) WAS PRESENT IN THE DEVICE TRACE DOWNLOAD AND PUMP ERROR 63 (VARIABLE 3) ALARMED DURING SELFTEST DUE TO BROKEN TRACE AT U1 PIN 6 (SDA) ON 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 BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423090 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2KVJJ 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR