BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK BLOOD GAS EGL CONTROL

    MDR report key: 7355467 · Received March 20, 2018

    Report

    Report Number
    2016706-2018-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 19, 2018
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    JJS
    UDI-DI
    00847661003540
    PMA / PMN Number
    K002535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIQUICHEK BLOOD GAS PLUS EGL CONTROL IS NOT MANUFACTURED FROM A BIOLOGICAL SOURCE MATERIAL. THIS PRODUCT IS A BUFFERED BICARBONATE AND ELECTROLYTE SOLUTION AND CONTAINS NO CONSTITUENTS OF HUMAN OR ANIMAL MATERIAL.

    Description of Event or Problem · 1

    THE COORDINATING ANALYST CONTACTED BIO-RAD TO REPORT A FINGER CUT INVOLVING LIQUICHEK BLOOD GAS PLUS EGL CONTROL, LOT 29510. THE LAB TECHNICIAN CUT A FINGER WHEN BREAKING AN AMPULE TO OPEN IT PRIOR TO RUNNING ON AN ANALYZER. THE TECHNICIAN RECEIVED CARE BY THE HOSPITAL'S EMERGENCY TEAM. THE INCIDENT OCCURRED IN THE HOSPITAL LABORATORY. THE TECHNICIAN WA NOT WEARING GLOVES OR USING AN AMPULE BREAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194697 LIQUICHEK BLOOD GAS EGL CONTROL CONTROLS FOR BLOOD-GASES (ASSAYED AND UNASSAYED) JJS BIO-RAD LABORATORIES, INC 29510 00847661003540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other