BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12710423 · Received October 28, 2021

    Report

    Report Number
    2032227-2021-211431
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    July 17, 2021
    Report Date
    October 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=CLEAR. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOAD USING (THUS SOFTWARE). UNIT PASSED DISPLACEMENT TEST AND SELF TEST PROPERLY. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY. NO UNEXPECTED AUDIO OR VIBRATION ANOMALIES NOTED. HOWEVER, PUMP ERROR 63 ALARM CONFIRMED IN PUMP HISTORY (VARIABLEINFO = 3) ON 06/08/2021, 07/06/2021, 07/07/2021, 07/11/2021 AND ON 07/17/2021, DUE TO BROKEN TRACE AT PIN #1 ON U1 KEYPAD ASSEMBLY. UNIT WAS CUT OPEN AND PERFORM A VISUAL INSPECTION ON ELECTRONIC ASSEMBLY AND MOTOR ASSEMBLY. NO MOISTURE DAMAGE OR COMPONENTS DAMAGE NOTED DURING VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS AND CRACKED CORNER OF BELT CLIP RAILS. (B)(4).

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. 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
    1614359 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2EZ1Q 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male