BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 750 CTS

    MDR report key: 11759548 · Received May 3, 2021

    Report

    Report Number
    1217183-2021-00001
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 3, 2021
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950784067
    PMA / PMN Number
    K150877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, SERVICE WAS DISPATCHED FOR ACL TOP 750 CTS ANALYZER AND INSTRUMENTATION LABORATORY (IL) REVIEWED THE ONLINE 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 750 CTS SPECIMEN PIERCER SINCE IT IS VERY SHARP. THE ACL TOP 750 CTS PERFORMED AS INTENDED WITH NO MALFUNCTION AND ITS LABELING PROVIDES APPROPRIATE WARNINGS TO THE USER REGARDING THE HAZARD OF THE SAMPLE PIERCER. THEREFORE, NO REMEDIAL ACTION IS INDICATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER WAS PERFORMING THE MANUAL NEEDLE CLEANING PROCEDURE OF THE PIERCER PROBE ASSEMBLY ON THE ACL TOP 750 CTS ANALYZER AND PUNCTURED HIS FINGER. FOLLOWING HOSPITAL PROTOCOL, TREATMENT WAS PROVIDED IN THE EMERGENCY ROOM OF THE HOSPITAL. MEDICAMENT AND BANDAGE WERE PROVIDED TO THE INJURED FINGER. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656209 ACL TOP 750 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-55 08426950784067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other