BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 350 CTS

    MDR report key: 15362713 · Received September 6, 2022

    Report

    Report Number
    1217183-2022-00004
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 6, 2022
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950784081
    PMA / PMN Number
    K150877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE INVESTIGATION, INSTRUMENTATION LABORATORY (IL) REVIEWED THE ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL. THE INVESTIGATION 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". THE ACL TOP 350 CTS 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

    IT WAS REPORTED THAT AN ACL TOP 350 CTS INSTRUMENT OPERATOR RECEIVED A SCRATCH ON THE THUMB OF HER GLOVED HAND WHILE TROUBLESHOOTING TO REMOVE A STUCK SAMPLE PROBE. A SAMPLE TUBE WAS LOADED INTO AN INCORRECT SAMPLE RACK, THUS RESULTING IN THE SAMPLE PROBE BEING STUCK IN THE SAMPLE TUBE. THE TECH SCRATCHED HER THUMB ON THE REAGENT PROBE WHILE ATTEMPTING TO REMOVE THE STUCK SAMPLE PROBE. THE STAFF MEMBER RECEIVED A BAND AID AND ANTI-VIRUS/ANTIBIOTIC TREATMENT AFTER REPORTING THIS INCIDENT. SHE ALSO FILED AN INCIDENT REPORT WITH THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143707 ACL TOP 350 CTS COAGULATION ANALYZER, PRODUCT CODE: GKP GKP INSTRUMENTATION LABORATORY CO. 2800-65 08426950784081

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other