BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 466567 · Received June 19, 2003

    Report

    Report Number
    2032227-2003-00406
    Event Type
    Injury
    Date Received
    June 19, 2003
    Date of Event
    May 27, 2003
    Report Date
    May 27, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER CALLED TO REPORT THAT THE PUMP HAD AN ERROR ALARMS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THEY WOULD CALL TO THE DR FOR BASAL INFO AND "SCT" AFTER RECEIVING THE REPLACEMENT PUMP. DURING THE CALL, THE FAMILY MEMBER STATED PT WAS HOSPITALIZED FOR LOW BGS. THE DR BELIEVED THAT IT WAS DUE TO PT'S MONITOR BEING OFF BY SIXTY POINTS LEADING TO A POSSIBLE OVER BOLUS THE PREVIOUS EVENING. THE DR HAS BEEN WORKING WITH THE CUSTOMER TO ADJUST THE BASAL RATES FOR OVERNIGHT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-507CUB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14. YR Hospitalization