BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY, SYSTEM, ACL TOP 750 LAS

    MDR report key: 20745498 · Received November 21, 2024

    Report

    Report Number
    1217183-2024-00007
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    November 11, 2024
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950784050
    PMA / PMN Number
    K242127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE SUBMITTED PHOTOS SHOWS ONE PHOTO OF THE BACK OF THE CUVETTE WASTE DRAWER WITH A BLOOD STAIN ON THE METAL PART OF THE PLATE SPRING AND ANOTHER PHOTO OF THE USER'S BANDAGED FINGER. THE INCIDENT IS RELATED TO USER ERROR -NOT USING PRECAUTION AS INSTRUCTED IN THE OPERATOR MANUAL. THE INVESTIGATION CONFIRMED THAT THERE ARE APPROPRIATE CAUTIONS REGARDING THE ACTIVITIES OF REMOVING CUVETTES FROM THE WASTE AREA OF THE INSTRUMENT. PER THE OPERATOR MANUAL THE CUVETTE WASTE CONTAINER IS PROPERLY LABELED AS "CUVETTE WASTE IS BIOHAZARDOUS. USE PRECAUTIONS WHEN EMPTYING THE CUVETTE WASTE DRAWER. REFER TO LOCAL AND STATE REGULATIONS FOR DISPOSAL OF POTENTIALLY HAZARDOUS MATERIALS". ACL TOP 750 LAS PERFORMED AS INTENDED WITH NO MALFUNCTION AND ITS LABELING PROVIDES APPROPRIATE INSTRUCTIONS AND CAUTIONS TO THE USER. THEREFORE, NO REMEDIAL ACTION IS INDICATED.

    Description of Event or Problem · 0

    A COMPLAINT FROM JAPAN WAS REPORTED ON 11/11/2024 REGARDING ASSY, SYSTEM, ACL TOP 750 LAS (PART NUMBER 00000280035) THAT MENTIONS THAT A STAFF MEMBER WAS INJURED BY A PART IN THE BACK OF THE CUVETTE WASTE BOX FROM INSTRUMENT ACL TOP 750 LAS SN (B)(6). WHEN SHE REMOVED THE BOX FROM THE INSTRUMENT AND PUT HER HAND ON IT, SHE CUT HER HAND ON THE METAL PART OF THE PLATE SPRING ON THE BACK OF THE BOX. IT WAS NOTED THAT BECAUSE OF THE RISK OF INFECTION, A STICKING PLASTERS WAS PUT ON WOUND SITE AND INJURED STAFF MEMBER WILL BE ALSO TAKING POST EXPOSURE DRUGS TO PREVENT AGAINST HIV VIRUS FOR 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460173 ASSY, SYSTEM, ACL TOP 750 LAS COAGULATION ANALYZER, GKP INSTRUMENTATION LABORATORY CO. 2800-35 08426950784050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other