BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 497582 · Received November 25, 2003

    Report

    Report Number
    2032227-2003-01290
    Event Type
    Injury
    Date Received
    November 25, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THEY WERE HOSPITALIZED FOR HIGH BLOOD SUGAR LEVELS. IT WAS INDICATED THAT THE CUSTOMER WAS NOT SURE WHY THEY HAD HBGS. THE CUSTOMER DID NOT TRY TO CHANGE OUT THEIR SET AND SITE PRIOR TO THE EVENT. IT WAS CONVEYED TO THE CUSTOMER TO FOLLOW THE TWO HBG RULE AND THAT THE HBG IS MOST OFTER CAUSED BY A SITE OR SET ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| S