BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 750 CTS

    MDR report key: 11097915 · Received December 30, 2020

    Report

    Report Number
    1217183-2020-00004
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 10, 2020
    Report Date
    December 30, 2020
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950784067
    PMA / PMN Number
    K150877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE ACL TOP 750 CTS BY THE SOFTWARE DEVELOPMENT TEAM DETERMINED THAT THE BARCODE WAS NOT MISREAD DUE TO A SOFTWARE DEFECT OR INSTRUMENT MALFUNCTION. THE SOFTWARE DEVELOPMENT TEAM INDICATED THAT A BARCODE MAY BE MISREAD DUE TO HUMAN FACTORS SUCH AS WHEN A LABEL IS TWISTED/TILTED HIDING PART OF THE BARCODE OR IF THE PRINTED LABELS ARE OF POOR QUALITY. IT IS LIKELY THAT THE BARCODE WAS NOT PLACED PROPERLY AND THEREFORE WAS MISREAD WHEN PLACED ON THE SAMPLE RACK. ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL, IN CHAPTER 4 INDICATES THE PROPER PLACEMENT IN "BAR CODE LABEL PLACEMENT". NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    THE COMPLAINT STATED THAT THERE WAS A MALFUNCTION OF THE BARCODE READER ON THE ACL TOP 750 CTS INSTRUMENT. THE INSTRUMENT BARCODE READER MISREAD A PATIENT SAMPLE IDENTIFICATION NUMBER AND THE SAMPLE RESULTS WERE ASSIGNED TO ANOTHER PATIENT. THE RESULTS WERE NOT TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS) AND THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560671 ACL TOP 750 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-55 08426950784067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other