BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP CTS

    MDR report key: 2616480 · Received June 8, 2012

    Report

    Report Number
    1217183-2012-00010
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    April 25, 2012
    Report Date
    June 8, 2012
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    JPA
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA BACKUP FROM THE CUSTOMER'S ACL TOP CTS INSTRUMENT WAS RETURNED TO IL AND IS CURRENTLY UNDER EVAL. BASED ON THE OUTCOME, IL WILL TAKE THE NECESSARY ACTIONS, INCLUDING BUT NOT LIMITED TO PERFORMING A RISK ASSESSMENT, IF NEEDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT SAMPLE RUN ON THEIR ACL TOP CTS INSTRUMENT GAVE AN INCORRECT PT RESULT. A RESULT OF 12.1 SECONDS WAS REPORTED BY THE INSTRUMENT, INSTEAD OF 130 SECONDS. NOTE: THERE WAS NO IMPACT ON PT TREATMENT RELATED TO THIS INCORRECT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TOP CTS COAGULATION INSTRUMENT JPA INSTRUMENTATION LABORATORY ACL TOP CTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1