BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 9177688 · Received October 10, 2019

    Report

    Report Number
    2032227-2019-101472
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    June 21, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. UNIT PASSED DISPLACEMENT TEST. UNIT RECEIVED WITH SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1 AND HARDWARE LOW LEVEL FAILURES (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 AND PUMP ERROR 63 (VARIABLE 3) ALARMED DURING SELF TEST DUE TO BROKEN TRACE AT PIN 6 (SDA) ON KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT MAKING ANY NOISES WHILE ALARMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT PASS THE AUDIO CHECK. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968146 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2QY33

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR