BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 505366 · Received January 8, 2004

    Report

    Report Number
    2032227-2004-00019
    Event Type
    Injury
    Date Received
    January 8, 2004
    Date of Event
    December 11, 2003
    Report Date
    December 11, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HBG. IT WAS STATED THAT THE CUSTOMER HAD NAUSEA AND DRY MOUTH. THE PROGRAMMING AND HISTORIES WERE ACCURATE. TROUBLESHOOTING WAS DONE AND THE PUMP PASSED THE FUNCTIONAL TESTS. IT WAS STATED THAT THE PUMP WAS OPERATING AS DESIGNED. 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-512LNAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization