BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL825 FLEX

    MDR report key: 2253025 · Received August 8, 2011

    Report

    Report Number
    3002807968-2011-00013
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    April 13, 2011
    Report Date
    July 4, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Removal / Correction Number
    RECALL Z-2571-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLOOD GAS ANALYSER GAVE FALSELY HIGH CA2+ RESULTS FOR A PT SAMPLE. NO FURTHER DETAILS AVAILABLE. THE INSTRUMENT HAD FAILED THE LOW QC'S (APPORX 0.50MM) FOR CA2+ FOR A LONGER PERIOD BEFORE THE EVENT WHICH OCCURRED ON 2011 (B)(6). FAN (B)(4) WAS ISSUED ON 2011-(B)(6), BUT HAD NOT YET REACHED THIS CUSTOMER AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL825 FLEX BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL825

    Patients

    Seq Age Sex Outcome Treatment
    1