BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 300 CTS

    MDR report key: 3117957 · Received May 7, 2013

    Report

    Report Number
    1217183-2013-00011
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS ORIGINALLY ASSESSED TO NOT QUALIFY AS A POTENTIALLY REPORTABLE INCIDENT. HOWEVER, BASED ON FURTHER INFO REVIEWED FOR POTENTIAL RISK ON (B)(4) 2013, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE AND IS CURRENTLY UNDER INVESTIGATION. A F/U REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FROM THIS INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS LOWERED QC RESULTS WHEN RUNNING HEMOSIL SYNTHASIL (APTT ASSAY) ON THEIR ACL TOP 300 CTS INSTRUMENT IN COMBINATION WITH RUNNING PT AND FIBRINOGEN-C TESTS. THE QC LEVEL 2 IS LOWERED 4-6 SECONDS THAN THE EXPECTED MEAN. WHEN THE CONTROL IS REPEATED, THE VALUE IS WITHIN 1 SD. CUSTOMER NOW RUNS QC FOR PT AND FIBRINOGEN-C IN ONE RUN AND APTT IN A SEPARATE RUN. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199398 ACL TOP 300 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1