BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2

    MDR report key: 16947420 · Received May 17, 2023

    Report

    Report Number
    2016706-2023-00002
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 17, 2023
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    JJY
    UDI-DI
    00847661000730
    PMA / PMN Number
    K050537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HEPATITIS B SURFACE ANTIGEN (HBSAG), ANTIBODY TO HEPATITIS C (HCV), AND ANTIBODY TO HIV-1/HIV-2. 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. THE COMPANY ADDRESS INFORMATION OF THE INITIAL REPORTER WAS NOT PROVIDED TO BIO-RAD.

    Description of Event or Problem · 0

    ON (B)(6) 2023, AN EMPLOYEE OF SIEMENS HEALTHINEERS REPORTED AN ACCIDENTAL BLOOD EXPOSURE AND FINGER CUT AT LABORATOIRE SYNLAB SYLAB FIGEAC AT COMBE DE LAVAYSSIÈRE, 46100 FIGEAC, FRANCE. THE EMPLOYEE NOTED THAT WHILE OPENING LIQUICHEK CARDIAC MARKER PLUS CONTROL LT, LEVEL 2, LOT 67672 AS PART OF A NEW AUTOMATON INSTALLATION, THE PRODUCT BOTTLE BURST AND CAUSED CUTS TO THE LEFT INDEX FINGER. A 5-DAY OF ANTIBIOTICS DOSE WAS GIVEN AND TESTS FOR HIV, HCV, AGHBS, AND SYPHILIS WERE CONDUCTED. BIO-RAD TECHNICAL SERVICE PROVIDED THE PRODUCT SAFETY DATA SHEET, AS WELL AS THE INSTRUCTIONS FOR USE (IFU) AND CERTIFICATE OF ANALYSIS FOR LOT 67672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602883 LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2 MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BIO-RAD LABORATORIES, INC. 147 67672 00847661000730

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other