BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYPOCHEK DIABETES CONTROL

    MDR report key: 4276165 · Received November 18, 2014

    Report

    Report Number
    2016706-2014-00003
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 23, 2014
    Report Date
    November 17, 2014
    Product Code
    GGM
    PMA / PMN Number
    K070546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS FOR LYPOCHEK DIABETES CONTROL INDICATES THAT EACH HUMAN WHOLE BLOOD DONOR UNIT USED TO MANUFACTURE THE PRODUCT WAS TESTED BY FDA ACCEPTABLE METHODS AND FOUND NON-REACTIVE FOR (B)(6) SURFACE ANTIGEN (B)(6), ANTIBODY TO (B)(6) AND ANTIBODY TO (B)(6). IN ADDITION, THE MANUAL INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USE WITH PATIENT SPECIMENS.

    Description of Event or Problem · 1

    A LABORATORY EMPLOYEE WAS PIPPETING LYPHOCHEK DIABETES CONTROL. WHILE DISCARDING A PIPET TIP CONTAINING THE CONTROL, THE TIP BOUNCED OFF THE SIDE OF THE BIOHAZARD WASTE CONTAINER AND HIT THE LABORATORY EMPLOYEE IN THE CORNER OF HER RIGHT EYE. THE LABORATORY EMPLOYEE REMOVED HER CONTACT LENS, IRRIGATED HER EYE AND SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745540 LYPOCHEK DIABETES CONTROL GGM NA 33881

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other