BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3098419 · Received April 24, 2013

    Report

    Report Number
    1217183-2013-00005
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 25, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, ON OCCASION, THEIR NORMAL AND HIGH ABNORMAL CONTROLS ARE LOW OUT OF RANGE USING HEMOSIL SYNTHASIL APTT REAGENT ON THEIR ACL TOP 500 CTS COAGULATION ANALYZER. WHEN REPEATED USING NEW VIALS OF REAGENT, THE RESULTS ARE WITHIN THE ACCEPTANCE RANGE. THE ISSUE HAS ALSO BEEN SEEN WITH PATIENT SAMPLES PERFORMED AT THE SAME TIME AS THE CONTROLS. ACCORDING TO THE CUSTOMER, THE ISSUE HAS ONLY HAPPENED WHEN THE APTT REAGENT HAS BEEN ON THE ACL TOP 500 CTS ANALYZER FOR A WHILE AND NEVER WITH A NEW VIAL OF REAGENT. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176683 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1