BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 750 LAS

    MDR report key: 20762833 · Received November 22, 2024

    Report

    Report Number
    1217183-2024-00008
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    November 20, 2024
    Report Date
    November 22, 2024
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950784050
    PMA / PMN Number
    K242127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS REPORTED ON (B)(6)2024 REGARDING ACL TOP 750 LAS SN (B)(6), INDICATING THAT THE PROBE SCRAPED ACROSS FINGERTIPS OF THE TECHNOLOGIST WHEN SHE REACHED TOO FAR IN PAST CONVEYOR BELT TRYING TO ALIGN CUVETTES ON ACL TOP 750 LAS SN (B)(6). IT WAS NOTED THAT THE GLOVE THE TECHNICIAN WAS WEARING WAS STILL INTACT BUT A SMALL SCRATCH WAS SEEN ON HER FINGERTIP. THE INCIDENT IS RELATED TO USER ERROR -NOT USING PRECAUTION AS INSTRUCTED IN THE OPERATOR MANUAL. THE ACL TOP SERIES OPERATOR'S MANUAL CONFIRMED THAT THERE ARE APPROPRIATE INSTRUCTIONS AND CAUTIONS AS BELOW: "WARNING PIERCING HAZARD: DO NOT PUT HAND INSIDE INSTRUMENT WHILE IT IS IN MOTION." "BIOHAZARD:THE SAMPLE PROBE AND PIERCER PROBE SHOULD BE TREATED AS BIOHAZARDOUS ITEMS. LABORATORY PRECAUTIONS FOR BIOHAZARDOUS MATERIAL SHOULD BE TAKEN WHEN HANDLING AND DISPOSING OF THESE ITEMS". THERE WAS NO KNOWN ADVERSE EFFECT FROM THE SCRAPE. THE ACL TOP 750 LAS 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 REPORTED ON (B)(6)2024 REGARDING ACL TOP 750 LAS SN (B)(6), INDICATING THAT THE PROBE SCRAPED ACROSS FINGERTIPS OF THE TECHNOLOGIST WHEN SHE REACHED TOO FAR IN PAST CONVEYOR BELT TRYING TO ALIGN CUVETTES ON ACL TOP 750 LAS SN (B)(6). IT WAS NOTED THAT THE GLOVE THE TECHNICIAN WAS WEARING WAS STILL INTACT BUT A SMALL SCRATCH WAS SEEN ON FINGERTIP. TECHNICIAN WENT TO EMERGENCY ROOM AND FOLLOWED UP WITH OCCUPATIONAL HEALTH. OCCUPATIONAL HEALTH PLACED HER ON A PEP FOR POTENTIAL EXPOSURE FOR 28 DAYS AND SCHEDULED FOLLOW-UP. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE SCRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799103 ACL TOP 750 LAS INSTRUMENT, COAGULATION, AUTOMATED GKP INSTRUMENTATION LABORATORY CO. 2800-35 08426950784050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other