BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3

    MDR report key: 9082451 · Received September 18, 2019

    Report

    Report Number
    2016706-2019-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJY
    UDI-DI
    00847661005186
    PMA / PMN Number
    K132227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROTOCOL PROVIDED BY BIO-RAD FOR TESTING THE LIQUICHEK IMMUNOASSAY PREMIUM CONTROL INDICATED THE PRODUCT CONTAINS HUMAN SOURCE MATERIALS AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS IN ACCORDANCE WITH GOOD LABORATORY PRACTICE. EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS PRODUCT WAS TESTED AS REQUIRED BY FDA ACCEPTED METHODS. TESTS RESULTS WERE NON-REACTIVE OR NEGATIVE FOR EVIDENCE OF INFECTION DUE TO HUMAN IMMUNODEFICIENCY VIRUS (HIV), HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV). THIS PRODUCT MAY ALSO CONTAIN OTHER HUMAN SOURCE MATERIALS FOR WHICH THERE ARE NO APPROVED TESTS. IN ACCORDANCE WITH GOOD LABORATORY PRACTICE, ALL HUMAN SOURCE MATERIAL SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH THE SAME PRECAUTIONS USED WITH PATIENT SPECIMENS.

    Description of Event or Problem · 1

    ON 08/21/2019, A NURSE FROM (B)(6) HOSPITAL CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT. THE NURSE STATED THAT ONE EMPLOYEES GOT THEIR RIGHT EYE SPLASHED WITH LEVEL 3 OF LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LOT # 27373. THE EYE WAS RINSED OFF. THE EMPLOYEE WAS NOT WEARING PROTECTIVE EYE WEAR. THE EMPLOYEE HAS THE VACCINATION FOR (B)(6). THE NURSE PRACTITIONER WILL DO A BASELINE TESTING AND MAKE DECISION ABOUT STARTING THE EMPLOYEE ON PROPHYLACTIC TREATMENT. THE NURSE INDICATED HAVING A COPY OF THE SDS AND BIO-RAD PROVIDED A COPY OF THE PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876455 LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3 MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BIO-RAD LABORATORIES, INC. 27373 00847661005186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other