BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CONTROL

    MDR report key: 3055343 · Received April 9, 2013

    Report

    Report Number
    1318354-2013-00001
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 8, 2013
    Manufacturer
    TRINITY BIOTECH PLC
    Product Code
    MZF
    PMA / PMN Number
    BP030025
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRINITY HAS CONFIRMED THE (B)(6) CONTROLS HAVE UNDERGONE CHEMICAL TREATMENT AND UV-INACTIVATION AND HAVE BEEN CERTIFIED AS (B)(6) AFTER A VIRUS CULTURE, AS WELL AS (B)(6) FOR (B)(6) AND THEREFORE THE RISK EXPOSURE IS DEEMED TO BE LOW. HOWEVER THE CONTROLS DO CONTAIN SODIUM AZIDE AS A PRESERVATIVE AND IS DESCRIBED ON THE MSDS. IT SHOULD BE NOTED THAT THE LABORATORY TECHNICIAN WAS NOT WEARING FULL COVERAGE GOGGLES OVER HER PRESCRIPTION GLASSES WHILE HANDLING THE MATERIAL. THIS PRACTICE WILL BE INSTITUTED BY (B)(6) MOVING FORWARD. TRINITY HAS REVIEWED THE DESIGN OF THE CONTROL VIALS AND DETERMINED THERE IS NO FAILURE DETECTED AND WAS A VERY UNFORTUNATE ISOLATED INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 TRINITY BIOTECH (TRINITY) TECHNICAL SERVICES RECEIVED A PHONE CALL FROM (B)(6). THEY HAD A "SPLASHING INCIDENT" INVOLVING A LABORATORY TECHNOLOGIST PERFORMING TESTING WITH THE TRINITY BIOTECH UNIGOLD RECOMBIGEN (B)(6). WHILE RUNNING THE TESTING, THE TECHNOLOGIST SPLASHED SOME OF THE CONTROL IN HER EYE, CATCHING THE TIP OF THE TRANSFER PIPETTE ON THE EDGE OF THE VIAL. SHE DID NOT KNOW IF IT WAS THE (B)(6) CONTROL (PRODUCT NUMBER 1206530, LOT NUMBER A198004). THE TECHNOLOGIST WAS WEARING PRESCRIPTION GLASSES, BUT NOT PROTECTIVE GOGGLES. SHE WAS ALSO WEARING PROTECTIVE GLOVES. THE MSDS SHEET FOR THIS PRODUCT WAS REVIEWED AND THEY IMMEDIATELY FLUSHED HER EYES WITH WATER FOR AT LEAST 15 MINUTES. THERE WERE NO PATIENT SAMPLES INVOLVED. TRINITY CONFIRMED BACK TO THE LABORATORY STAFF THAT BOTH THE (B)(6) CONTROL MATERIAL HAVE UNDERGONE CHEMICAL AND UV INACTIVATION STEPS AND ARE FOUND (B)(6) FOR (B)(6). BOTH CONTROLS CONTAIN SODIUM AZIDE AS A PRESERVATIVE AND THIS IS LISTED ON THE MSDS, HENCE THE REQUIREMENT FOR FLUSHING EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148075 TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CONTROL MZF, TEST, HIV DETECTION MZF TRINITY BIOTECH PLC A198004

    Patients

    Seq Age Sex Outcome Treatment
    1