BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 550 CTS

    MDR report key: 10303571 · Received July 21, 2020

    Report

    Report Number
    1217183-2020-00003
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 21, 2020
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950729242
    PMA / PMN Number
    K150877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, INSTRUMENTATION LABORATORY (IL) REVIEWED THE ONLINE HELP DOCUMENTATION (ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL). THE INVESTIGATION CONFIRMED THAT THERE ARE APPROPRIATE INSTRUCTIONS AND CAUTIONS REGARDING THE ACTIVITIES OF CLEANING AND REMOVING CUVETTES FROM THE WASTE AREA OF THE INSTRUMENT. PER THE ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL, THE OPERATOR ACTION TO ADDRESS THE TWO ALARMS PRESENTED DURING THE INCIDENT IS TO PERFORM A RECOVERY AND IF THE ALARM PERSISTS TO CALL FOR SERVICE. IL CONFIRMED THAT THE LABORATORY TECHNICIAN DID NOT CALL IL SERVICE OR THE TECHNICAL SERVICE HELPLINE WHILE PERFORMING THESE ACTIVITIES. THE ACL TOP 550 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 · 1

    IT WAS REPORTED THAT AN ACL TOP 550 CTS INSTRUMENT OPERATOR DEVELOPED A LACERATION RESULTING IN BLEEDING ON THE FINGER OF HER GLOVED HAND. THIS INCIDENT OCCURRED WHILE TROUBLESHOOTING TO CLEAN AND REMOVE CUVETTES FROM THE WASTE AREA OF THE INSTRUMENT. THE STAFF MEMBER RECEIVED MEDICAL ATTENTION IN THE EMERGENCY DEPARTMENT AT THE HOSPITAL AND FILED AN INCIDENT REPORT. NO STITCHES WERE NECESSARY. THE STAFF MEMBER WAS PLACED ON MEDICATION FOR (B)(6) PROPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765090 ACL TOP 550 CTS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-45 08426950729242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other