BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8665800 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11194
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 28, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO/VIBRATE/ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE FAILED THE AUDIO TEST DURING THE CALL. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS 191 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462034 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2FF2N 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR