BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8099159 · Received November 23, 2018

    Report

    Report Number
    2032227-2018-65268
    Event Type
    Injury
    Date Received
    November 23, 2018
    Date of Event
    May 29, 2018
    Report Date
    November 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED DISPLACEMENT TEST AND SELF TEST. HARDWARE LOW LEVEL FAILURE ALARM (VARIABLE INFO=3) CONFIRMED IN THE PUMP HISTORY DUE TO COLD SOLDER JOINT ON U1 KEYPAD ASSEMBLY. (PIN 6).

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURE ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 287, 150, 363, 300 MG/DL. THE CUSTOMER WAS TREATED WITH SYRINGES AND PENS. THE TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT THEY HAD PERFORMED THE SELF TEST AND THE TEST WAS PASSED. THE CUSTOMER WAS NEITHER IN EMERGENCY, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938891 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG1UQ8L 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR