BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP

    MDR report key: 3663267 · Received December 20, 2013

    Report

    Report Number
    1217183-2013-00019
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 29, 2013
    Report Date
    December 20, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY IS STILL INVESTIGATING THIS COMPLAINT, AND A FOLLOW UP REPORT WILL BE FILED. ATTEMPTS TO GAIN INFO FROM THIS SITE HAVE BEEN DIFFICULT. FOLLOW UP WITH THE CUSTOMER IS CONTINUING.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEIR ACL TOP ANALYZER GAVE A SHORT APTT RESULT (22.3 SECONDS). WHEN THE CUSTOMER RAN THE TEST AGAIN, THEY RECEIVED A RESULT OF 33.2 SECONDS. THE ORIGINAL RESULT OF 22.3 SECONDS WAS NOT REPORTED, AND THERE WAS NO PT IMPACT. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670643 ACL TOP COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK