BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3098418 · Received April 24, 2013

    Report

    Report Number
    1217183-2013-00006
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FROM THIS INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR QC AND PATIENT APTT RESULTS HAVE BEEN DECREASED BY ABOUT 10 SECONDS ON THEIR ACL TOP 500 CTS WHEN USING HEMOSIL SYNTHASIL REAGENT. PER MANUFACTURER'S INSTRUCTIONS, THEY HAVE CLEAN B IN THE APPROPRIATE POSITION. THE CUSTOMER HAS A SECOND ANALYZER, WITH THE SAME EXACT REAGENT CONFIGURATION, WHICH DOES NOT SHOW THIS PROBLEM. THERE WAS NO REPORTED ADVERSE EVENT. NO BACK-UP DATA FROM THE ANALYZER HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176392 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1