BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP,INSULIN,512 NA PURPLE,REFURBISH

    MDR report key: 547168 · Received October 1, 2004

    Report

    Report Number
    2032227-2004-01817
    Event Type
    Injury
    Date Received
    October 1, 2004
    Date of Event
    September 6, 2004
    Report Date
    September 6, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS CALLED REGARDING TO A BATTERY AND BOLUS ISSUES. IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. IT WAS FOUND THAT CUSTOMER NEVER ACTIVATED BOLUS. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED CUSTOMER TO CALL MMI ONCE CLAMP IS RECEIVED TO DO HP TEST. BGS WERE TREATED WITH INJECTION. INSTRUCTED CUSTOMER TO CALL BACK IF PROBLEM PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,INSULIN,512 NA PURPLE,REFURBISH INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512RNAP *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization