BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A

    MDR report key: 9745217 · Received February 24, 2020

    Report

    Report Number
    2016706-2020-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 24, 2020
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJY
    UDI-DI
    00847661004172
    PMA / PMN Number
    K050537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTION FOR USE PROVIDED BY BIO-RAD FOR TESTING THE LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT 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 FOR (B)(6) SURFACE (B)(6), ANTIBODY TO (B)(6), AND ANTIBODY TO (B)(6) 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 (B)(6) 2020, A MEDICAL TECHNOLOGIST FROM (B)(6) LAB CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT THAT OCCURRED WITH AN EMPLOYEE AT THEIR FACILITY. THE EMPLOYEE WAS OPENING A VIAL OF LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A, LOT # 23694 AND THE CONTENTS SPLASHED ONTO HER RIGHT EYE WHILE NOT WEARING SAFETY GOGGLES. THE EMPLOYEE WASHED AND FLUSHED HER EYES AND ALSO WASHED HER FACE. THE INCIDENT WAS REPORTED TO FACILITIES HEALTH AND THE EMPLOYEE WAS SEEN BY A DOCTOR. NO MEDICAL TESTS WERE DONE. THE EMPLOYEE HAD ALL THE SCREENINGS DONE AT PRE-EMPLOYMENT TIME. THE EMPLOYEE AND FACILITY HAVE ACCESS TO PRODUCT'S PACKAGE INSERT, MSDS AND COA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210809 LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BIO-RAD LABORATORIES, INC. 27104 23694 00847661004172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other