BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP CTS

    MDR report key: 3098443 · Received April 24, 2013

    Report

    Report Number
    1217183-2013-00007
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 10, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FROM THIS INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR QC RESULTS ON THEIR ACL TOP CTS INSTRUMENT WITH HEMOSIL SYNTHASIL APTT REAGENT DROPPED LOW BETWEEN 9:00 AM AND 12:00 PM (SEE RESULTS BELOW). PER THEIR LAB PROCEDURE, CUSTOMER RERAN ALL APTT SPECIMENS BETWEEN LAST GOOD QC RUN AT 9:00 AM AND THE QC RUN AT 12:00 PM. A TOTAL OF 30 PATIENT SPECIMENS WERE RERUN, OF WHICH 11 HAD TO BE CORRECTED BECAUSE THEY WENT FROM NORMAL TO ABNORMAL. THE REMAINING SPECIMENS STAYED WITHIN NORMAL RANGE EVEN THOUGH THE RESULTS MAY HAVE INCREASED SLIGHTLY. THE ISSUE WAS NOT RESOLVED UNTIL FRESH HEMOSIL SYNTHASIL APTT REAGENT WAS PREPARED. QC RESULTS IN SECONDS: SEE SCANNED PAGE. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176687 ACL TOP CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1