BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 6010726 · Received October 7, 2016

    Report

    Report Number
    1217183-2016-00003
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 14, 2016
    Manufacturer
    INSTRUMENTATION LABORATORY - BEDFORD
    Product Code
    GKP
    PMA / PMN Number
    K160276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LABORATORY (IL) INVESTIGATED THE DATA BACK-UP AND CLOT CURVES OF THE SAMPLES ANALYZED. A REVIEW OF THE ACL TOP 500 CTS GENERAL LOG LIST INDICATES THERE WERE NO ANALYZER ERRORS OR WARNINGS NEAR THE TIME OF THE EVENT OCCURRENCE. A FIELD SERVICE ENGINEER (FSE) PERFORMED A VISUAL INSPECTION OF THE ANALYZER AND DID NOT SEE ANYTHING OUT OF THE NORMAL, NO LEAKS OR LOOSE CONNECTORS. SAMPLE PROBE AND REAGENT PROBE APPEAR TO BE FINE AND NOT DAMAGED. HE RAN A FLUIDIC PRECISION TEST ON BOTH PROBES. THE Y INTERCEPT WAS SLIGHTLY OUT FOR THE REAGENT PROBE, SO HE PERFORMED ALL OPTICAL READING UNIT (ORU) AIR AND FACTOR DILUENT BLANKINGS. HE THEN RE-RAN SAMPLE AND REAGENT PROBE FLUIDIC PRECISION TEST AGAIN AND ALL VALUES WERE IN RANGE. IL WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE INITIAL APTT HIGH RESULT. THE ACL TOP 500 CTS PERFORMED AS INTENDED AND THERE IS NO INDICATION OF A SYSTEM MALFUNCTION. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER STATED THAT SURGERY TO PLACE A SHUNT ON A PATIENT DIAGNOSED WITH RENAL FAILURE WAS DELAYED DUE TO A HIGH APTT RESULT OF 103.2 SECONDS REPORTED ON AN ACL TOP 500 CTS. THERE WAS NO OTHER ADVERSE EFFECT TO THE PATIENT OTHER THAN THE PROCEDURE DELAY. A SECOND TEST WAS REPEATED FROM THE SAME TUBE WITH A RESULT OF 34.5 SECONDS, AND A REDRAWN SAMPLE WAS ANALYZED ON THE SAME DAY WITH A RESULT OF 35.0 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663076 ACL TOP 500 CTS COAGULATION ANALYZER, PRODUCT CODE GKP GKP INSTRUMENTATION LABORATORY - BEDFORD 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other