BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 3802024 · Received February 12, 2014

    Report

    Report Number
    3002807968-2014-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 9, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS CAUSED BY A USE ERROR. THE USER DID NOT SCAN THE BARCODE AFTER REPLACING THE MEMBRANES AS DESCRIBED IN THE OPERATORS MANUAL PAGE 7-3, AND NO CALIBRATION WAS; THEREFORE, RUN AFTER THE REPLACEMENT.

    Description of Event or Problem · 1

    TWO PATIENTS WERE INVOLVED IN THIS EVENT. THE GLUCOSE AND REFERENCE MEMBRANE WERE CHANGED, BUT THE LOT NO. FOR EACH MEMBRANE WAS NOT SCANNED IN REPLACEMENT STATUS AND NO CALIBRATION WAS; THEREFORE, RUN AFTER THE REPLACEMENT. AFTER 30 MINUTES, THE OPERATOR CHECKED THE ABL AND DISCOVERED THE ERROR. HOWEVER, DURING THE 30 MINUTES, TWO SAMPLES HAD ALREADY BEEN RUN. ICU PERSONAL THOUGHT THAT THE RESULTS WERE STRANGE AND RAN AN EXTRA SAMPLE ON THE ABL FOR COMPARISON, BUT THE RESULTS WERE THE SAME. AS A CONSEQUENCE, ONE PATIENT WAS GIVEN ACTRAPID FOR HIGH GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92705 ABL800 FLEX ABL825 CHL RADIOMETER MEDICAL APS ABL825

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR