BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL827 FLEX

    MDR report key: 3415181 · Received September 27, 2013

    Report

    Report Number
    3002807968-2013-00016
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Date of Event
    August 20, 2013
    Report Date
    August 28, 2013
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K051968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO STATED IN THE COMPLAINT THE LAB DOES NOT CHANGE THE REFERENCE MEMBRANE OFTEN ENOUGH. THE LAB RUNS ABOUT 40 SAMPLES PER DAY AND CHANGE THE REFERENCE MEMBRANE MONTHLY. ACCORDING TO THE ABL800 OPERATOR'S MANUAL P. 3.49 THE FOLLOWING PROCEDURE SHOULD BE FOLLOWED: REPLACING REFERENCE ELECTRODE MEMBRANES: LESS THAN OR EQUAL TO 40 SAMPLES PER DAY: ABL8X7 FLEX ANALYZERS 14 DAYS; GREATER THAN 40 SAMPLES PER DAY: ABL8X7 FLEX ANALYZERS 1 WEEK. THE DATA LOGS FROM THE ANALYZER HAVE BEEN INVESTIGATED AND THERE ARE NO CALIBRATION ERRORS OR ERROR MESSAGES IN THE SYSTEM MESSAGE LOG. HOWEVER, THE QCS RUN AFTER THE LOW K+ SAMPLE FAILED. THE CUSTOMER CHANGED BOTH THE REFERENCE MEMBRANE AND K+ MEMBRANE AFTER THE EVENT AND THIS HAS SOLVED THE PROBLEM. BASED ON THE AVAILABLE DATA THIS SUGGESTS THAT THE ROOT CAUSE OF THE EVENT WAS EITHER THE REFERENCE MEMBRANE OR THE K+ MEMBRANE. IT IS NOT POSSIBLE TO IDENTIFY IF ONLY ONE OR BOTH OF THE MEMBRANES CAUSED THE PROBLEM AND IT IS NOT POSSIBLE TO INVESTIGATE USED MEMBRANES AS THEY WOULD DRY OUT DURING TRANSPORT. THE ROOT CAUSE OF THIS EVENT CAN THEREFORE NOT BE CONFIRMED, BUT THE CUSTOMER HAS BEEN ADVISED TO CHANGE THE REFERENCE MEMBRANE ACCORDING TO THE MANUAL.

    Description of Event or Problem · 1

    THE ANALYZER GAVE A FALSE LOW K+ RESULT ON A SAMPLE FROM A PEDIATRIC PT. THE FIRST RESULT ON THE SAMPLE MEASURED ON (B)(6) 2013, AT 11:15 PM, GAVE 2.1MMOL/L. THE SENSOR HOSPITAL PEDIATRICIAN WAS CALLED IN AT MIDNIGHT TO PUT IN A LINE TO ADMINISTER IV K+ TO THE CHILD BUT WAS TOLD BY THE ED STAFF THAT ALL THE K+ RESULTS WERE LOW. REPEAT K+ ON THE ICU ANALYZER GAVE A RESULT OF 3.0MMOL/L. BASED ON THIS IT WAS DECIDED NOT TO ADMINISTER K+ TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491454 ABL827 FLEX ABL827 FLEX CHL RADIOMETER MEDICAL APS ABL827 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO