BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 550 CTS

    MDR report key: 20622329 · Received November 6, 2024

    Report

    Report Number
    1217183-2024-00006
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 6, 2024
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950729242
    PMA / PMN Number
    K242127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INDICATES THAT AN OPERATOR ACCIDENTALLY PUNCTURED HIS FINGER ON THE PROBE WHILE TRYING TO UNLOCK IT. IT WAS ALSO NOTED THAT A COLLEAGUE PLACED A CLOSED TUBE IN THE WRONG RACK (WITHOUT A CAP) AND THE NEEDLE GOT STUCK, HE PRICKED HIS FINGER WHEN UNLATCHING THE PERFORATOR AND THE TUBE. THE ACL TOP SERIES OPERATOR'S MANUAL CONFIRMED THAT THERE ARE APPROPRIATE INSTRUCTIONS AND CAUTIONS REGARDING THE ACTIVITIES OF A STUCK OR JAMMED CTS PIERCER PROBE IN THE CAP OF A PRIMARY SAMPLE TUBE. PER THE ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL; " WARNING PIERCING HAZARD: DO NOT PUT HAND INSIDE INSTRUMENT WHILE SAMPLE ARM IS IN MOTION. CAUTION BIOHAZARD: IN THE UNLIKELY EVENT THAT THE CTS PIERCER PROBE GETS STUCK OR JAMMED IN THE CAP OF A PRIMARY SAMPLE TUBE, DO NOT ATTEMPT TO REMOVE THE CAP. CALL SERVICE FOR ASSISTANCE. THE CTS PIERCER PROBE ASSEMBLY IS DELICATE, VERY SHARP, AND BIOHAZARDOUS. THE REMOVAL OF A STUCK CAP FROM THE PIERCER PROBE COULD CAUSE PERSONAL INJURY OR DAMAGE TO THE INSTRUMENT". NO REMEDIAL ACTION REQUIRED. THE ACL TOP 550 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

    A COMPLAINT WAS FILED ON OCTOBER 25, 2024 REGARDING ACL TOP 550 CTS SN (B)(6) INDICATING USER ACCIDENTALLY PUNCTURED HIS FINGER ON PROBE WHILE TRYING TO UNLOCK IT. COMPLAINT MENTIONED THAT A COLLEAGUE PLACED A CLOSED TUBE IN THE WRONG RACK (WITHOUT A CAP) AND THE NEEDLE GOT STUCK, AND THE USER PRICKED HIS FINGER WHEN UNLATCHING THE PERFORATOR AND THE TUBE. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991613 ACL TOP 550 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-45 08426950729242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other