BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT

    MDR report key: 1353990 · Received March 31, 2009

    Report

    Report Number
    2016706-2009-00001
    Event Type
    Other
    Date Received
    March 31, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 26, 2009
    Manufacturer
    BIO-RADD, LABORATORIES
    Product Code
    JJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS OF THE CONTROL MATERIAL INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS TESTED BY FDA-ACCEPTED METHODS AND FOUND NON-REACTIVE FOR (B)(6). IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PT SPECIMENS. ROOT CAUSE OF EVENT: USER ERROR.

    Description of Event or Problem · 1

    A LAB PROFESSIONAL SPLASHED CONTROL MATERIAL IN HER EYE. SHE WAS TRYING TO REMOVE BUBBLES FROM AN INSTRUMENT CUVETTE WHEN THE PIPETTE TIP 'CAUGHT' AND FLICKED THE CONTROL MATERIAL IN HER EYE. THERE WAS NO IMMEDIATE HARM TO THE LAB PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT QUALITY CONTROL (ASSAYED AND UNASSAYED) JJT BIO-RADD, LABORATORIES NA 23450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other