BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3117959 · Received May 7, 2013

    Report

    Report Number
    1217183-2013-00009
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 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 REPORTED A PROBLEM WITH HEMOSIL SYNTHASIL APTT REAGENT ON THEIR ACL TOP 500 CTS INSTRUMENT. ACCORDING TO THEIR REPORT, THEY RAN QC AT 6:00 AM AND THE NORMAL LEVEL WAS 30.9 SECONDS AND THE ABNORMAL LEVEL WAS 59.9 SECONDS. THE REAGENT WAS LEFT ON UNIT AND QC RERUN AT 2:00 PM. THE NORMAL LEVEL WAS 24.9 SECONDS AND THE ABNORMAL LEVEL WAS 43.9 SECONDS. WHEN FRESH REAGENT WAS USED, THE QC RESULTS WERE ACCEPTABLE WITH NORMAL LEVEL AT 30.3 SECONDS AND ABNORMAL LEVEL AT 57.5 SECONDS. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199998 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1