BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INSULIN, 512 NAL BLUE, LOANER

    MDR report key: 536961 · Received July 30, 2004

    Report

    Report Number
    2032227-2004-01268
    Event Type
    Injury
    Date Received
    July 30, 2004
    Date of Event
    July 4, 2004
    Report Date
    July 4, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BGS. THE CUSTOMER STATED THAT FOR A FEW DAYS, THE ACTIVATE BUTTON HAS NOT BEEN WORKING PROPERLY. THE CUSTOMER HAS TO PRESS SEVERAL TIMES IN ORDER FOR IT TO WORK. SUGGESTED THE CUSTOMER TO MONITOR BGS CLOSELY AND HAVE BACK UP PLAN INJECTIONS READY. FEW DAYS LATER THE CUSTOMER CALLED BACK AND REPORTED THAT CUSTOMER WAS HOSPITALIZED FOR DKA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization