BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8743495 · Received June 28, 2019

    Report

    Report Number
    2032227-2019-22715
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND DISPLACEMENT TEST. DEVICE POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED DURING TESTING. DEVICE RECEIVED WITH NORMAL OPERATING CURRENTS, NO FAILED BATTERY TEST ALARMS NOTED DURING TESTING. NO UNEXPECTED REPLACE BATTERY NOW ALARMS, OR LOW BATTERY ALARMS NOTED DURING TESTING. NO DEVICE HEATING UP NOTED DURING TESTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS OFF. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THAT OVERALL INSULIN PUMP WAS HOT. THE INSULIN PUMP HAD BLANK DISPLAY AND THE CONTACT ON THE BATTERY CAP WAS NEITHER DAMAGED NOR CORRODED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537270 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG36S29 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR