BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 6064063 · Received October 28, 2016

    Report

    Report Number
    1217183-2016-00004
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 24, 2016
    Report Date
    October 7, 2016
    Manufacturer
    INSTRUMENTATION LABORATORY - BEDFORD
    Product Code
    GKP
    PMA / PMN Number
    K160276
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, 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 SPECIMEN PIERCER. 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 OF THE SAMPLE PIERCER. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER PUNCTURED THEIR FINGER WHILE CLEANING THE SPECIMEN PIERCER OF THE ACL TOP 500 CTS SYSTEM. NO SUTURES OF THE PUNCTURE WERE REQUIRED, BUT THE USER RECEIVED (B)(6) TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713832 ACL TOP 500 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY - BEDFORD 2800-40

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other