BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIER I

    MDR report key: 2462046 · Received February 21, 2012

    Report

    Report Number
    1319808-2012-00003
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    January 28, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT APPEARS IN THE WARNINGS AND PRECAUTIONS OF THE IFU FOR PERFORMANCE VERIFIER I:" HANDLE AS IF CAPABLE OF TRANSMITTING DISEASE. THIS PRODUCT IS PREPARED FROM HUMAN SERUM AND HUMAN ENZYMES. EACH DONOR UNIT USED IN THE PREPARATION OF THE PRODUCT HAS BEEN TESTED AND FOUND TO BE (B)(6) FOR (B)(6) USING FDA APPROVED METHODS. HOWEVER, SINCE NO TEST CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT, THIS PRODUCT SHOULD BE HANDLED FOLLOWING THE RECOMMENDATIONS MADE IN CLSI GUIDELINE M29 1 OR OTHER PUBLISHED BIOHAZARD SAFETY GUIDELINES. THIS PRODUCT SHOULD BE HANDLED USING THE SAME PRECAUTIONS AS WITH ANY OTHER BLOOD OR BLOOD-DERIVED PRODUCT." IT IS KNOWN THAT SOME PERSONAL PROTECTIVE EQUIPMENT, A LAB COAT AND GLOVES WERE BEING WORN AT THE TIME OF THE EVENT, HOWEVER SAFETY GLASSES OR A FACE SHIELD WERE NOT BEING WORN AT THE TIME OF THE EVENT. IMMEDIATELY AFTER THE INCIDENT, THE OPERATOR FLUSHED THE AFFECTED EYE WITH WATER. THE OPERATOR¿S VISION WAS CHECKED AND NO PROBLEMS WERE FOUND. THE OPERATOR IS FEELING WELL, IS ON THE JOB WITH NO EFFECTS, AND NO ADDITIONAL TREATMENT OR TESTING IS ANTICIPATED. THE PERFORMANCE VERIFIER I FLUID WAS TESTED FOR EXPOSURE TESTING, AND THE RESULTS WERE NEGATIVE (SPECIFIC TESTS AND RESULTS WERE NOT PROVIDED). THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR SPLASHED VITROS PERFORMANCE VERIFIER I INTO THEIR EYE. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE. THERE WAS NO IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIER I IN-VITRO DIAGNOSTIC JJX ORTHO-CLINICAL DIAGNOSTICS V1189

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.