BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 500 CTS

    MDR report key: 3663227 · Received December 20, 2013

    Report

    Report Number
    1217183-2013-00021
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 21, 2013
    Report Date
    December 20, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENTATION LAB IS STILL INVESTIGATING AND REVIEWING THE BACK UP INFO SENT TO US BY THE SITE FOR THIS INSTRUMENT. A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT ACL TOP 520 ANALYZER GAVE A SHORT APTT RESULT ON A CAP PROFICIENCY SAMPLE (25 SECONDS). WHEN THE CUSTOMER RAN THE TEST AGAIN, THEY RECEIVED A RESULT OF 33 SECONDS. THE CUSTOMER WAS RUNNING A CAP SURVEY AT THE TIME OF EVENT, SO NO PTS WERE IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670502 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK