BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3940540 · Received April 18, 2014

    Report

    Report Number
    1217183-2014-00005
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    January 28, 2014
    Report Date
    March 19, 2014
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INSTITUTED SOME SAFEGUARDS IN THEIR LABORATORY THAT INCLUDE REPEATING ANY APTT VALUE OF <20 SECONDS ON A SECOND ANALYZER, AND INCLUDING DELTA CHECKS IN THEIR LIS SYSTEM TO FLAG RESULTS THAT ARE NOTED TO BE BEYOND THE NORMAL VARIATION OF SAMPLE TO SAMPLE DIFFERENCES. THIS ISSUE APPEARS TO HAVE BEEN WELL CHARACTERIZED BY THE SITE AND APPROPRIATE ACTION HAS BEEN TAKEN TO RECOGNIZE ABERRANT VALUES AND ASSESS THE NEED TO RETEST. THERE WAS NO INDICATION OF AN INSTRUMENT OR REAGENT MALFUNCTION. THEREFORE, NO REMEDIAL ACTION IS REQUIRED BY INSTRUMENTATION LABORATORY CO.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN INSTRUMENTATION LABORATORY REPRESENTATIVE BECAME AWARE OF AN INCIDENT THAT OCCURRED AT (B)(6) ON (B)(6) 2014. THE CUSTOMER INDICATED THAT THEIR ACL TOP 500 CTS REPORTED 17 ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. PER THEIR DESCRIPTION OF THE EVENT, THE FIRST PATIENT SAMPLE CONTAINED A CLOT AND THEY BELIEVE THAT IT CONTAMINATED THE INSTRUMENT, CAUSING THE ERRONEOUS 17 TEST RESULTS. OF THE AFFECTED PATIENT SAMPLES, 4 OF 17 WERE HEPARINIZED PATIENTS. AS A RESULT, 3 OF THE 4 PATIENTS HAD THEIR HEPARIN DOSAGE CHANGED BASED ON THE INCORRECT APTT RESULTS. ALL WERE SUBSEQUENTLY CORRECTED WHEN THE SAMPLES WERE REPEATED AND CORRECTED RESULTS OBTAINED. THERE WERE NO ASSOCIATED ADVERSE EVENTS WITH THIS SAMPLE HANDLING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238499 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1