BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3089586 · Received April 17, 2013

    Report

    Report Number
    1217183-2013-00003
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 INFORMATION REVIEWED FOR POTENTIAL RISK ON (B)(6) 2013, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE AND IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FORM THIS INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER WAS PERFORMING CROSS-OVER STUDIES AND REPORTED LOWERED APTT RESULTS ON BOTH PT AND CONTROL SAMPLES IN COMPARISON TO RESULTS FROM TWO SISTER HOSPITALS. THE LOWERED RESULTS WERE SEEN WHEN THE APTT AND PT REAGENTS WERE RUN IN THE SAME RACK ON THEIR ACL TOP 500 CTS COAGULATION ANALYZER. WHEN THE APTT AND PT REAGENTS WERE MOVED INTO SEPARATE RACKS, RESULTS AGREED WITH THE OTHER TWO HOSPITALS. THERE WAS NO REPORTED ADVERSE EVENT. PER THE CUSTOMER, NO PT RESULTS WERE REPORTED OUT AND NO PTS WERE IMPACTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165592 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1