BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 16 TRI-LEVEL CONTROL

    MDR report key: 80010 · Received March 25, 1997

    Report

    Report Number
    2919069-1997-00002
    Event Type
    Other
    Date Received
    March 25, 1997
    Date of Event
    March 3, 1997
    Report Date
    March 25, 1997
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JPK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 03/03/97, A MEDICAL ASSISTANT AT THE ACCOUNT, SPLASHED CONTROL REAGENT INTO HER EYE, WHILE MIXING THE REAGENT VIALS. SHE WAS NOT WEARING EYE PROTECTION AT THE TIME, BUT WAS WEARING GLOVES. ACCORDING TO THE ACCOUNT, THE CONTROLS HAD BEEN OPENED PREVIOUSLY AND THE CAPS WERE LOOSE WHEN THE MEDICAL ASSISTANT STARTED MIXING THE VIALS. AFTER THE EVENT, SHE WAS REFERRED TO THE EMPLOYEE HEALTH DEPARTMENT. THE CUSTOMER HAD BEEN ADVISED OF THE REAGENT WARNINGS AND PRECAUTIONS LOCATED IN THE PACKAGE INSERT. THE EMPLOYEE HAS COMPLETED THE HEPATITIS B ANTIBODY SERIES. SHE WAS RECENTLY DRAWN FOR A BASELINE HIV AND WILL HAVE AN HIV ANTIBODY TEST FOLLOWED FOR 1 YEAR. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 16 TRI-LEVEL CONTROL CELL-DYN 16 TRI-LEVEL HEMATOLGY CONTROL JPK ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA 16461

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other