BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3117960 · Received May 7, 2013

    Report

    Report Number
    1217183-2013-00008
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    October 22, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 SPORADICALLY LOWERED APTT RESULTS ON THEIR ACL TOP 500 CTS WITH HEMOSIL SYNTHASIL APTT REAGENT. CUSTOMER INDICATED THAT WHEN A NEW VIAL OF PT REAGENT IS PUT ON THE SAME RACK WITH THE APTT REAGENT, ALL APTT RESULTS WERE LOWERED APPROX 10 SECONDS. HOWEVER, WHEN THE TWO REAGENTS ARE SEPARATED ONTO DIFFERENT RACKS IN THE INSTRUMENTS, RESULTS REPORT APPROPRIATELY. THE CUSTOMER IS QUESTIONING POSSIBLE CARRYOVER. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199399 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1