BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 512348 · Received February 20, 2004

    Report

    Report Number
    2032227-2004-00276
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 19, 2004
    Report Date
    January 19, 2004
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA. PRIOR TO THE EVENT, THE CUSTOMER STATED THAT THEY GAVE LARGE AMOUNT OF INSULIN AND BGS DID NOT COME DOWN. IT WAS INDICATED THAT THE CUSTOMER DID NOT FOLLOW THE TWO HBG RULE. IN ADDITION, THE CUSTOMER WAS INSTRUCTED TO CHANGE OUT ENTIRE SET AND WAS EDUCATED ON 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-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization