BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 504807 · Received January 6, 2004

    Report

    Report Number
    2032227-2004-00008
    Event Type
    Injury
    Date Received
    January 6, 2004
    Date of Event
    August 29, 2003
    Report Date
    December 8, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HBGS. THE CUSTOMER HAD AWAKENED IN THE MORNING WITH A HBG WITH KETONES. IT WAS INDICATED THAT THE CUSTOMER TOOK A MANUAL INJECTION, BUT DID NOT CHANGE OUT THE SET. AT THE HOSPITAL, THE CUSTOMER WAS TREATED WITH AN INSULIN DRIP. THE MD MADE NO DETERMINATION OF THE CAUSE FOR EVENT. 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-511USC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization