BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK URINALYSIS CONTROL

    MDR report key: 873140 · Received June 28, 2007

    Report

    Report Number
    2016706-2007-00002
    Event Type
    Other
    Date Received
    June 28, 2007
    Date of Event
    June 10, 2007
    Report Date
    June 22, 2007
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJW
    PMA / PMN Number
    K070848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS INDICATE THAT THE SERUM FROM EACH DONOR CONTRIBUTING URINE FOR THIS PRODUCT WAS TESTED AND FOUND NON-REACTIVE AT THE DONOR LEVEL PER CURRENT APPLICABLE FDA REQUIREMENTS USING FDA ACCEPTED METHODS INCLUDING TESTING FOR HIV-1/HIV-2 ANTIBODY, HBSAG, HCV ANTIBODY, HIV-1 AND HCV BY A NUCLEIC ACID TEST (NAT). IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN CUT HER RIGHT INDEX FINGER WHILE CAPPING A TEST TUBE THAT CONTAINED LEVEL 2 CONTROL MATERIAL. THE LAB TECHNICIAN WAS WEARING GLOVES AT THE TIME OF THE EVENT AND IMMEDIATELY WASHED HER HANDS WITH SOAP AND WATER AND APPLIED NEOSPORIN AND A BAND-AID. THE LAB TECHNICIAN DID NOT REQUIRE ANY STITCHES OR HOSPITALIZATION; HOWEVER, THE LAB TECHNICIAN REPORTED THE EVENT TO THE HOSPITAL FACILITY'S OCCUPATIONAL HEALTH DEPARTMENT AND RECEIVED A TETANUS. THERE WAS NO IMMEDIATE HARM TO THE LABORATORY PROFESSIONAL AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK URINALYSIS CONTROL NONE JJW BIO-RAD LABORATORIES NA 61272

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other