BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 3885948 · Received June 20, 2014

    Report

    Report Number
    3002809144-2014-00141
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED ON AN INTERNATIONAL PRODUCT (8L44) WHICH HAS A SIMILAR PRODUCT (6L22) DISTRIBUTED IN THE US. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    A CORRECTION HAS BEEN MADE TO TYPE OF REPORTABLE EVENT. TICKET SEARCHES DETERMINED THAT THERE IS NO ATYPICAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT AND THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED AS THE ASSAY PACKAGE INSERT INDICATED THAT THE MICROPARTICLES IN THE REAGENT BOTTLE IS AN IRRITANT SUBSTANCE AND SAFETY GLASSES SHOULD BE USED WHILE HANDLING THIS PRODUCT. THE PACKAGE INSERT ALSO LISTED ACTIONS TO FOLLOW IN CASE AN EYE CONTACT OCCURRED. SINCE SAFETY GLASSES WERE NOT USED DURING THIS INCIDENT, THE ISSUE IS DETERMINED TO BE DUE TO USE ERROR AND NO MALFUNCTION OR PRODUCT DEFICIENCY COULD BE IDENTIFIED AS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INJURY HAS HAPPENED WHILE INSTALLING THE ARCHITECT ANTI-HBC REAGENT SEPTUM ON A MICROPARTICUL BOTTLE. THE OPERATOR WAS WEARING GLOVES AND CLOTHES BUT WAS NOT WEARING GLASSES WHEN ONE DROP OF THE MICROPARTICUL REAGENT SPLASHED INTO HIS EYES. THE OPERATOR WASHED HIS EYES AND FACE WITH TAB WATER AND THE DOCTOR RECOMMENDED TO USE AN ANTISEPTIC EYE DROPS FOR PRECAUTION. THE TECHNICIAN HAS BEEN PREVIOUSLY VACCINATED FOR THE (B)(6) PANEL. NO FURTHER IMPACT OR OUTCOME TO THE OPERATOR HEALTH WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363280 ARCHITECT ANTI-HBC II ANTI-HBC LOM ABBOTT GERMANY 37355LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARCHITECT I2000SR 03M74-02 SN (B)(4)| ARCHITECT I2000SR 03M74-02 SN (B)(4)