BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK DIABETES CONTROL LEVEL 1

    MDR report key: 7906291 · Received September 25, 2018

    Report

    Report Number
    2016706-2018-00004
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 24, 2018
    Manufacturer
    BIO-RAD LABORATORIES INC
    Product Code
    GGM
    UDI-DI
    00847661000839
    PMA / PMN Number
    K052838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING FOR LIQUICHEK DIABETES CONTROL INDICATES THIS PRODUCT IS MANUFACTURED FROM HUMAN SOURCE MATERIAL COMPONENTS. THE LABELING HAS A WARNING STATEMENT AND A CAUTION SYMBOL INDICATING THE PRODUCT CONTAINS HUMAN SOURCE MATERIAL AND MUST BE TREATED AS POTENTIALLY INFECTIOUS. 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.

    Description of Event or Problem · 1

    ON SEPTEMBER 06, 2018, BIO-RAD QSD, (B)(4) RECEIVED A REPORT FOR A POTENTIAL ADVERSE EVENT WHERE A LABORATORY TECHNICIAN SPLASHED LIQUICHEK DIABETES CONTROL LOT # 38560 INTO HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749356 LIQUICHEK DIABETES CONTROL LEVEL 1 HEMOGLOBIN CONTROL GGM BIO-RAD LABORATORIES INC 38561 00847661000839

    Patients

    Seq Age Sex Outcome Treatment
    1 Other