BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 700 CTS

    MDR report key: 7138949 · Received December 21, 2017

    Report

    Report Number
    1217183-2017-00008
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 21, 2017
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950497981
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IL INVESTIGATION DETERMINED THAT THE ACL TOP SOFTWARE IS FUNCTIONING CORRECTLY ACCORDING TO THE CUSTOMER'S TEST CONFIGURATION AND THAT THERE IS NO MALFUNCTION OF OUR DEVICE OR SOFTWARE. THEREFORE, NO REMEDIAL ACTION INDICATED. IL WILL WORK WITH THE CUSTOMER TO RESOLVE THE PROBLEM, WHICH IS LIKELY ATTRIBUTABLE TO THEIR LIS.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED INDICATING THAT ACL TOP 700 CTS, S/N (B)(4), GENERATED XA RESULTS THAT CROSSED TO THEIR (B)(6) INFORMATION SYSTEM (LIS) AS <0.04 DUE TO A QC FLAG ASSOCIATED WITH THE RESULTS. FOUR PATIENTS WERE ADMINISTERED UNNECESSARY HEPARIN BASED ON REPORTED RESULTS. THERE WAS NO REPORTED ADVERSE EFFECT ON THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917137 ACL TOP 700 CTS ACL TOP GKP INSTRUMENTATION LABORATORY CO. 2800-50 08426950497981

    Patients

    Seq Age Sex Outcome Treatment
    1 Other