BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 16948092 · Received May 17, 2023

    Report

    Report Number
    1217183-2023-00001
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 17, 2023
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950453499
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE INVESTIGATION, INSTRUMENTATION LABORATORY (IL) REVIEWED THE ON-LINE HELP DOCUMENTATION (OPERATOR'S MANUAL) AND CONFIRMED THAT THERE ARE APPROPRIATE INSTRUCTIONS AND WARNINGS REGARDING THE CLEANING OF THE PIERCER PROBE ASSEMBLY. THE INSTRUCTIONS INCLUDE A WARNING NOT TO PLACE A FINGER UNDER THE ACL TOP 500 CTS SPECIMEN PIERCER SINCE IT IS VERY SHARP. THE ACL TOP 500 CTS PERFORMED AS INTENDED WITH NO MALFUNCTION AND ITS LABELING PROVIDES APPROPRIATE WARNINGS TO THE USER REGARDING THE HAZARD. THEREFORE, NO REMEDIAL ACTION IS INDICATED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER WAS INJURED DURING MAINTENANCE PROCEDURE "CLEAN DEEP WASH AND CLEAN CUP AREA". THE CUSTOMER CLEANED THE SAMPLE CUP AREA AND AFTER THIS OPERATION TURNED UP THE FOOTER AND WAS INJURED WITH THE PIERCER. THE CUSTOMER WAS WEARING GLOVES. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542074 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-40 08426950453499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other