BEUDAMED
    FDA Adverse Event Summary report: N

    ACL TOP

    MDR report key: 602784 · Received May 13, 2005

    Report

    Report Number
    1217183-2005-00003
    Date Received
    May 13, 2005
    Report Date
    May 13, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THAT THEIR ACL TOP DID NOT FLAG AN ERRONEOUS PROTHROMBIN TIME (PT) RESULT. THE PT REAGENT IN USE WAS HEMOSIL RECOMBIPLASTIN [510(K) NO. K043184]. IN THIS RARE OCCURRENCE, THE ACQUISITION TIME (STANDARD AND/OR EXTENDED) DID NOT ALLOW SUFFICIENT TIME TO CAPTURE THE ENTIRE CLOTTING REACTION. DUE TO THIS AND THE FACT THAT THE BASELINE NOISE MET ALL DATA REDUCTION CRITERIA, THE CLOT POINT WAS INCORRECTLY IDENTIFIED WITHIN THE BASELINE. THE CASE INVOLVED AN OVER-ANTICOAGULATED PATIENT WITH AN UNUSUALLY ELEVATED INR (9.8), CONSIDERABLY HIGHER THAN THE THERAPEUTIC RANGE OF 1.5-4.5. NOTE: TO CO'S KNOWLEDGE, THERE WAS NO IMPACT ON PATIENT TREATMENT WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP AUTOMATED COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. TOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN