BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, NA, INSULIN, 715, CLEAR

    MDR report key: 685992 · Received March 13, 2006

    Report

    Report Number
    2032227-2006-00468
    Event Type
    Injury
    Date Received
    March 13, 2006
    Date of Event
    February 21, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS HOSPITALIZED FOR DKA. MOTHER STATED THAT IT WAS DETERMINED THAT THE INSULIN CUSTOMER WAS USING IN PUMP WAS BAD. MOTHER WAS ALSO CONCERNED AS TO SHY THER WERE 0.0 UNIT BOLUS ESTIMATES WHEN USING BOLUS WIZARD FETURE. ACTIVE INSULIN AND BOLUS WIZARD FEATURE WERE EXPLAINED TO MOTHER ACCORDINGLY. MOTHER STATED THAT SHE WAS NO LONGER CONCERNED WITH THE PUMP'S PERFORMANCE AT THE END OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, NA, INSULIN, 715, CLEAR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization