BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8905150 · Received August 19, 2019

    Report

    Report Number
    2032227-2019-48560
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 9, 2019
    Report Date
    October 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, AND OCCLUSION TEST OR VERIFY PUMP ERROR 37, 43, OR 130 ALARMS, OR INSULIN FLOW BLOCKED ALARMS DUE TO BLANK DISPLAY. ALSO, RECEIVED WITH MOISTURE DAMAGE ON THE MOTOR AND FORCE SENSOR.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 147 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. CUSTOMER STATED THAT THEY REWOUND INSULIN PUMP AND THE PISTON ONLY WENT HALF WAY DOWN. CUSTOMER STATED THAT THERE WAS FLUID IN THE RESERVOIR COMPARTMENT. CUSTOMER PERFORMED SELF TEST AND IT WAS PASSED. CUSTOMER WAS UNABLE TO CLEAR THE PUMP ERROR ALARM, HOWEVER ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER PERFORMED DISPLACEMENT TEST AND INSULIN PUMP RECEIVED ANOTHER PUMP ERROR WHILE DISPLACEMENT TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700095 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2K1KX 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR