BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CNT

    MDR report key: 1038736 · Received April 23, 2008

    Report

    Report Number
    1318354-2008-00001
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 23, 2008
    Manufacturer
    TRINITY BIOTECH PLC,
    Product Code
    MVW
    PMA / PMN Number
    BP030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRINITY HAS CONFIRMED THE POSITIVE MATERIAL USED TO MFR THE POSITIVE CONTROL HAS UNDERGONE CHEMICAL TREATMENT (1 BPUV (VIRUCIDAL AGENT) AND UV-IRRADIATION AND HAS BEEN CERTIFIED NEGATIVE AFTER A VIRUS CULTURE ASSAY, THEREFORE, DEEM THE EXPOSURE RISK TO BE LOW. HOWEVER, IT SHOULD BE NOTED THE LAB TECH WAS USING THE PRODUCT OUTSIDE OF THE RECOMMENDED SAFE LABORATORY PRACTICES, AS HE WAS NOT WEARING GLOVES WHILE HANDLING THE MATERIAL.

    Description of Event or Problem · 1

    IN 2008, TRINITY BIOTECH (TRINITY) TECHNICAL SERVICES RECEIVED A PHONE CALL FROM THE SUPERVISING NURSE OF FACE TO FACE'S SAFE ZONE. THEY HAD AN EXPOSURE INCIDENT INVOLVING A LABORATORY TECHNOLOGIST PERFORMING TESTING WITH THE TRINITY BIOTECH UNIGOLD RECOMBIGEN POSITIVE CONTROL. FACE TO FACE'S SAFE ZONE IS LOCATED AT 1 SUPPORT FACE TO FACE. THE TECHNOLOGIST WAS HANDLING THE POSITIVE CONTROL (KIT LOT NO. R065001, POSITIVE CONTROL LOT NO. R05108) WITHOUT WEARING GLOVES AND SOME OF THE FLUID SPLASHED ON HIS RIGHT HAND (FINGERTIP). THE TECHNOLOGIST FELT A ''BURNING SENSATION" AND RINSED WITH WATER, THEN USED AN ALCOHOL WIPE. IT WAS NOTED THERE WERE NO OPEN SORES OR CUTS ON HIS HAND. THE MEDS SHEET FOR THE PRODUCT WAS FAXED TO THE SITE FOR THEIR REVIEW. TRINITY HAS ALSO CONFIRMED THE POSITIVE MATERIAL USED TO MFR THE POSITIVE CONTROL HAS UNDERGONE CHEMICAL TREATMENT (1 BPUV (VIRUCIDAL AGENT) AND UV-IRRADIATION AND HAS BEEN CERTIFIED NEGATIVE AFTER A VIRUS CULTURE ASSAY. THE TECHNICIAN WAS FOLLOWED UP BY THE STAFF NURSE AND A BLOOD SAMPLE WAS DRAWN FOR BASELINE TESTING AND WILL BE SCHEDULED FOR FOLLOW UP TESTING TO OCCUR AT 3 TO 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CNT NONE MVW TRINITY BIOTECH PLC, R065001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR