BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL700

    MDR report key: 2220322 · Received August 15, 2011

    Report

    Report Number
    1523456-2011-00002
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FSE CHANGED UNITS TO MMOL/L FOR CA++ WHEN RUNNING A CAL VERIFICATION AND DID NOT RETURN THE UNITS TO THE CUSTOMER'S USUAL SETTING. THE USER RAN A PT SAMPLE AND TREATED THE PT FOR CRITICALLY LOW IONIZED CALCIUM RESULTS WITHOUT READING THE UNITS ON THE PT RESULT. THE TREATMENT WAS BASED UPON MG/DL WHICH WAS THE USERS ACCUSTOMED SETTING. THE PT WAS ADMINISTERED A BOLUS OF CALCIUM GLUCONATE 190 MG. TREATMENT WAS INTERRUPTED BEFORE THE FULL AMOUNT WAS GIVEN. THE PT'S FOLLOWING CA++ WAS 5.39 MG/DL, HIGH IN THE NORMAL REFERENCE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL700 BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention