BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INSULIN, 512 NA BLUE

    MDR report key: 552639 · Received November 1, 2004

    Report

    Report Number
    2032227-2004-02040
    Event Type
    Injury
    Date Received
    November 1, 2004
    Date of Event
    October 12, 2004
    Report Date
    October 12, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED DUE TO DKA. SIGNIFICANT EVENT LEADING TO HOSPITALIZATION. CAUSE OF HOSPITALIZATION AS PER (MD) DKA. CUSTOMER WAS ON THE DRIP BEFORE CALLING MMI. INSTRUCTED CUSTOMER TO CHANGE OUT SET AND INJECT AS PER MD. TROUBLESHOOTING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, INSULIN, 512 NA BLUE INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAB *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization