BEUDAMED
    FDA Adverse Event Summary report: N

    ACL ADVANCE

    MDR report key: 597190 · Received April 22, 2005

    Report

    Report Number
    1217183-2005-00002
    Date Received
    April 22, 2005
    Report Date
    April 22, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THAT THEIR ACL ADVANCE COAGULATION ANALYZER DID NOT FLAG AN ERRONEOUS PROTHROMBIN TIME (PT) RESULT. THE PT REAGENT IN USE WAS HEMOSIL RECOMBIPLAS TIN [510(K) NO. K043184]. IN THIS RARE OCCURRENCE, THE ACQUISTION TIME (STANDARD AND/OR EXTENDED) DID NOT ALLOW SUFFICIENT TIME TO ACQUIRE DATA AND THEREFORE, THE BASELINE NOISE MET THE CRITERIA TO DEFINE THE CLOT POINT. THE CASE INVOLVED A PT WITH AN UNUSALLY ELEVATED INR (>7.0), CONSIDERABLY HIGHER THAN THE THERAPEUTIC RANGE OF 1.5-4.5. A SECOND SAMPLE WAS ALSO MISREPORTED, BUT FLAGGED WITH A WARNING "FIRST POINT IS WITHIN ROI [REGION OF INTEREST]". FOR THIS FLAG, THE OPERATOR'S MANUAL DIRECTS CUSTOMERS TO "REVIEW CURVE, IF NO VISIBLE FAILURES, REPORT RESULTS". A REVIEW OF THE CLOT CURVE FOR THIS RESULT SHOWED IT TO BE CLEARLY ABNORMAL. NOTE: TO OUR KNOWLEDGE, THERE WAS NO IMPACT ON PT TREATMENT WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL ADVANCE SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA INSTRUMENTATION LABORATORY CO. ADVANCE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN