BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP

    MDR report key: 3663213 · Received December 20, 2013

    Report

    Report Number
    1217183-2013-00018
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INSTRUMENT'S BACK UP INDICATED THAT THE CUSTOMER IS USING THE IL LOCKED TEST AND IL REAGENTS FOR APTT-SS. QC WAS FOUND TO BE WITHIN THE LAB'S ESTABLISHED RANGES. CLOT CURVES FOR BOTH RESULTS APPEARED TO BE APPROPRIATE. NO WARNINGS OR ERRORS WERE NOTED IN THE GENERAL LOG THAT WOULD CAUSE INTERFERENCE AT THE TIME OF TESTING FOR THIS PT'S SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEIR ACI TOP ANALYZER GAVE A SHORT APTT RESULT (18.4 SECONDS). WHEN THE CUSTOMER RAN THE TEST AGAIN, THEY RECEIVED A RESULT OF 28.9 SECONDS. THE ORIGINAL RESULT OF 18.4 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
    670629 ACL TOP COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK