BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL827 FLEX

    MDR report key: 2992945 · Received March 1, 2013

    Report

    Report Number
    3002807968-2013-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    November 22, 2012
    Report Date
    January 30, 2013
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CGL
    PMA / PMN Number
    K051968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SOLVED THE FIRST CAUSE OF THE PROBLEM BY REPLACING THE MEMBRANES. THERE WAS AN ERROR CODE '(951) - KREATINE LIGT ONDER DE RAPPORTEERGRENS' ON THE FIRST RESULT AFTER MEASUREMENT #(B)(6). OTHERWISE THERE ARE NO ERROR CODES IN CONNECTION WITH THE REGARDED MEASUREMENT RESULTS. IN THE QC-LOG THERE IS AN ERROR ON EVERY QC RESULT S7835 (LOW CREA, APPROX 200UM) BETWEEN 11/19/2012 AND 11/28/2012. THIS IS THE PERIOD WHERE THE REGARDED MEMBRANE WAS USED. THIS IS 14 FAILED OUT OF 30 QC RESULTS FOR THIS MEMBRANE. ON THE LAST QC MEASUREMENTS FOR THIS MEMBRANE THE S7855 ALSO FAILS (APPROX 600UM). IN THE CAL-LOG THERE ARE TWO BIG DRIFT3 ERRORS. ONE ON (B)(6) 2012 9:53 (-15, 6UM) AND ONE ON (B)(6) 2012 9:19 (-23, 1 UM). OTHERWISE NO ERRORS. THIS EVAL OF THE INSTRUMENT DATA POINTS TOWARDS A SINGLE DEFECT CREA-MEMBRANE. AS THE MEMBRANE WAS DISCARDED BY THE CUSTOMER, A ROOT CAUSE COULD NOT BE ESTABLISHED. THE CUSTOMER CAN CHOOSE IF THE ANALYZER SHOULD WARN ABOUT QC ERRORS ON THE PT RESULTS OR NOT, AND HOW QC ERRORS SHOULD AFFECT THE COLOR OF THE FRONT MENU TRAFFIC LIGHT. IT IS SUSPECTED THAT WARNINGS WERE DEACTIVATED IN THE INSTRUMENT SETUP. FURTHER INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT PT RESULTS FOR CREA WERE TOO HIGH COMPARED WITH THE CLINICAL STATUS OF THE PT, WHILE QC VALUES WERE OK. CREA RESULTS WERE ALSO HIGHER THAN VALUES MEASURED ON A ROCHE MODULAR ANALYZER. AFTER REPLACING MEMBRANES THE VALUES WERE BETTER COMPARABLE. THERE WERE NO WARNING ABOUT FAILED QC'S ON THE PT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90876 ABL827 FLEX ABL827 FLEX CGL RADIOMETER MEDICAL APS ABL827 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR