BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2

    MDR report key: 6955643 · Received October 17, 2017

    Report

    Report Number
    2016706-2017-00002
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 17, 2017
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    OHQ
    UDI-DI
    00847661000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIO-RAD SHIPPING BOXES WERE LABELED AS REQUIRED BY THE UNITED STATES DEPARTMENT OF TRANSPORTATION (DOT) AND THE (B)(6)) FOR DRY ICE USING A "MISCELLANEOUS" HAZARD SYMBOL, CLASS 9.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING SEVERAL BOXES OF BIO-RAD CONTROLS, PACKED WITH DRY ICE. THE SHIPPING BOXES WERE PLACED INTO THE WALK-IN REFRIGERATOR. THE NEXT DAY TWO EMPLOYEES WALKED INTO THE REFRIGERATOR AND REPORTED TO THEIR SUPERVISOR THAT THEY EXPERIENCED A "FEELING OF SUFFOCATION AND/OR THROAT AND CHEST IRRITATION AND DRY MOUTH." BOTH EMPLOYEES WERE SENT TO THE EMERGENCY DEPARTMENT WHERE THEY WERE EXAMINED BY A TOXICOLOGIST MD. THEY RECEIVED AN EKG, PHYSICAL EXAMINATIONS, AND THEIR VITALS WERE MONITORED. THEY WERE SENT HOME. NO HOSPITALIZATION WAS REQUIRED AND NO FURTHER TREATMENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736276 LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2 MULTI-ANALYTE CONTROLS UNASSAYED OHQ BIO-RAD LABORATORIES, INC. 31832 00847661000013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other