BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP

    MDR report key: 719995 · Received July 21, 2005

    Report

    Report Number
    1217183-2005-00006
    Event Type
    Malfunction
    Date Received
    July 21, 2005
    Report Date
    July 21, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACL TOP COAGULATION ANALYZER DID NOT FLAG AN ERRONEOUS PROTHROMBIN TIME (PT) RESULT. THE PT REAGNET IN USE WAS HEMOSIL RECOMBIPLAS TIN ([510(K) NO. K043184]. CUSTOMER REPORTED A PT RESULT OF 8 SECONDS. PT WAS REDRAWN AND FAILED EXTENDED MODE WAS RUN ON THE INSTRUMENT AND A PT RESULT OF 111 SECONDS WAS REPORTED. SOMETIME DURING THIS PERIOD, THE COUMADIN PT WAS GIVEN HEPARIN. THE DR. THOUGHT THAT THE PT WASN'T RESPONDING TO COUMADIN AND NEEDED HER MEDICATED. INTERNAL REVIEW OF THE INSTRUMENT BACKUP DETERMINED THAT THE BASELINE NOISE MET ALL DATA REDUCTION CRITERIA AND CLOT POINT WAS INCORRECTLY IDENTIFIED WITHIN THE BASELINE. NOTE: TO OUR KNOWLEDGE, THERE WAS NO ADVERSE EVENT RELATED TO THE CHANGE IN TREATMENT.

    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