BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2

    MDR report key: 8044607 · Received November 6, 2018

    Report

    Report Number
    2016706-2018-00005
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    OHQ
    UDI-DI
    00847661000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), A HEALTH COORDINATOR FROM THE (B)(6), CALLED BIO-RAD TO INQUIRE ABOUT LIQUICHEK UNASSAYED CHEMISTRY CONTAINING ANY INFECTIOUS DISEASE MATERIAL IN THE PRODUCT. SHE STATED THAT A TECHNICIAN SPLASHED A SMALL AMOUNT OF THE LEVEL 2 CONTROL INTO HER EYE WHILE PIPETTING THE CONTROL FROM THE PRIMARY VIAL INTO ANOTHER VIAL WHICH WAS GOING TO BE PLACED ON AN INSTRUMENT. THEY HAD THE TECHNICIAN FLUSHED OUT THE EYE WITH WATER FOR SEVERAL MINUTES. THEY ALSO CONDUCTED THE FOLLOWING MEDICAL TESTS: (B)(6). NO OTHER DETAILED INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), A HEALTH COORDINATOR FROM THE (B)(6), CALLED BIO-RAD TO INQUIRE ABOUT LIQUICHEK UNASSAYED CHEMISTRY CONTAINING ANY INFECTIOUS DISEASE MATERIAL IN THE PRODUCT. SHE STATED THAT A TECHNICIAN SPLASHED A SMALL AMOUNT OF THE LEVEL 2 CONTROL INTO HER EYE WHILE PIPETTING THE CONTROL FROM THE PRIMARY VIAL INTO ANOTHER VIAL WHICH WAS GOING TO BE PLACED ON AN INSTRUMENT. THEY HAD THE TECHNICIAN FLUSHED OUT THE EYE WITH WATER FOR SEVERAL MINUTES. THEY ALSO CONDUCTED THE FOLLOWING MEDICAL TESTS: (B)(6). NO OTHER DETAILED INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881121 LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2 MULTI-ANALYTE CONTROL,UNASSAYED ,PRODUCT CODE OHQ OHQ BIO-RAD LABORATORIES 31872 00847661000013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other