BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL

    MDR report key: 9806089 · Received March 9, 2020

    Report

    Report Number
    2016706-2020-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJY
    UDI-DI
    00847661001119
    PMA / PMN Number
    K001373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTION FOR USE (IFU) PROVIDED BY BIO-RAD FOR TESTING LIQUICHEK IMMUNOASSAY PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, AND LIQUID ASSAYED MULTIQUAL INDICATED PRODUCTS CONTAIN 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. LIQUICHEK IMMUNOASSAY PLUS CONTROL HAS A HAZARDOUS WARNING CONTAIN SODIUM AZIDE AS A PRESERVATIVE. SODIUM AZIDE CAN REACT WITH COPPER, BRASS, LEAD, AND SOLDER IN PIPING SYSTEMS TO FORM EXPLOSIVE COMPOUNDS OF LEAD AZIDE AND COPPER AZIDE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A LABORATORY INFORMATION MANAGER FROM (B)(6) MEDICAL CENTER- (B)(6) CALLED BIO-RAD QSD TECHNICAL SUPPORT TO REPORT A POTENTIAL ADVERSE EVENT THAT OCCURRED WITH A TECHNICIAN AT THEIR FACILITY. IN THE FACILITY CHEMISTRY LAB, THE EMPLOYEE REMOVED QC RACK FROM INSTRUMENT AND EMPTIED A RACK OF QC VIALS INTO SINK. WHILE DUMPING, THE MIXTURE OF QC SPLASHED INTO THE TECHNICIAN'S EYES. THE TECHNICIAN WAS NOT WEARING SAFETY GLASSES, WHICH IS A LABORATORY REQUIREMENT FOR PPE IN THIS FACILITY. THE FOLLOWING QC PRODUCTS WERE ON THE QC RACK AND PLASHED IN THE TECHNICIAN'S EYES: LIQUICHEK IMMUNOASSAY PLUS CONTROL: TRILEVEL: LOT 41000. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT: LEVEL 2: LOT 23692, LEVEL 3: LOT 23693, LEVEL 1B: LOT 23695. LIQUID ASSAYED MULTIQUAL: LEVEL 1: LOT 45791, LEVEL 3: LOT 45793. THE EMPLOYEE WASHED EYES IMMEDIATELY IN THE EMERGENCY EYE WASH STATION. THE INCIDENT WAS REPORTED TO FACILITIES HEALTH AND THE EMPLOYEE WAS SENT TO THE EMPLOYEE HEALTH CENTER FOR EVALUATION. NO DETAILS OF THE VISIT TO EMPLOYEE HEALTH CENTER WAS PROVIDED. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE EMPLOYEE AND FACILITY WAS PROVIDED WITH PACKAGE INSERT, SDS AND CERTIFICATE OF ANALYSIS FOR ALL 8 PRODUCTS THAT WERE SPLASHED IN THE TECHNICIAN'S EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269744 LIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BIO-RAD LABORATORIES, INC. 360 41000 00847661001119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other