BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 501046 · Received December 15, 2003

    Report

    Report Number
    2032227-2003-01381
    Event Type
    Injury
    Date Received
    December 15, 2003
    Date of Event
    November 17, 2003
    Report Date
    November 17, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DKA. IT WAS INDICATED THAT THE PUMP ALARMED OFF NO POWER. THE FAMILY MEMBER STATED THE CUSTOMER BOLUSED TO TREAT HBG. THE PROGRAMMING ON THE PUMP WAS ACCURATE AND THE PUMP PASSED THE FUNCTIONAL TESTS. IT WAS INDICATED THAT THE SET WAS IN USE FOR TWO DAYS. THE FAMILY MEMEBER WAS ADVISED 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-511NAB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization