BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 11641239 · Received April 9, 2021

    Report

    Report Number
    1061932-2021-00058
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590701567
    PMA / PMN Number
    K162414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO IMPACT TO PATIENTS AS A RESULT OF THIS EVENT. THE FSE HAD A BATTERY OF TESTS PERFORMED FOR POSSIBLE INFECTIOUS DISEASES ON THE SAME DAY OF THE CUT, ALL TESTS HAD NEGATIVE RESULTS. THE FSE WAS PRESCRIBED A PROPHYLAXIS COCKTAIL (DULOTEGRAVIR SODIUM AND TENOFOVIR DESAPROXIL FUMARATE + LUMIVUDINE). BESIDES THE INITIAL BASELINE TESTING, THE FSE WILL HAVE ADDITIONAL TESTING AT SCHEDULED INTERVALS TO MONITOR HIS HEALTH. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE WORKING ON THE DXH SMS INSTRUMENT HE RECEIVED A SMALL CUT ON HIS LEFT THUMB FROM A BROKEN SLIDE. AT THE TIME OF THE INJURY THE FSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) WHICH INCLUDED GLOVES. THE SLIDE MAY CONTAIN BIOHAZARDOUS MATERIAL FROM PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537035 UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN,DXH SLIDEMAKER STAINER II 15099590701567

    Patients

    Seq Age Sex Outcome Treatment
    1 Other