BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 508214 · Received January 28, 2004

    Report

    Report Number
    2032227-2004-00109
    Event Type
    Injury
    Date Received
    January 28, 2004
    Date of Event
    December 24, 2003
    Report Date
    December 24, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DKA. IT WAS STATED THAT THE TWO HBG RULE WAS NOT FOLLOWED AND THE MD IS UNSURE OF THE CAUSE FOR THE EVENT. THE CUSTOMER STATED THAT THE LAST SET CHANGE WAS TWO TO THREE DAYS PRIOR TO THE EVENT. THE PROGRAMMING AND HISTORIES WERE ACCURATE. IN ADDITION, THE PUMP PASSED THE FUNCTIONAL TESTS. IT WAS INDICATED THAT THE CUSTOMER WAS INSTRUCTED TO FOLLOW THE TWO HBG RULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-512NAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization