BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 3096334 · Received May 7, 2013

    Report

    Report Number
    3002809144-2013-00123
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLIANT INFORMATION AND A REVIEW OF LABELING. ACCORDING TO INFORMATION FROM CUSTOMER SERVICE THE CUSTOMER DID NOT WEAR SAFETY GLASSES WHEN THE ISSUE OCCURRED. THEREFORE THE USER INJURY IS RELATED TO INCORRECT USE. REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED AND LABELING IS ADEQUATE. TICKET SEARCHES FOR THE LIKELY CAUSE LOT COULD NOT BE PERFORMED SINCE LIKELY CAUSE LOT IS UNKNOWN. BASED ON THIS DATA, THE PRODUCT IS PERFORMING AS INTENDED AND NO PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HIV AG/AB COMBO LIST 4J27, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 2P36.

    Description of Event or Problem · 1

    THE CUSTOMER WAS LOADING A NEW REAGENT KIT ONTO THE ARCHITECT I2000 SR ANALYZER. AS SHE PREPARED TO CLOSE THE SEPTUM ON THE ANALYZER, HIV AG/AB COMBO DILUENT (TRIS BUFFER) SPLASHED INTO HER EYE. SHE FLUSHED HER EYE WITH TAP WATER AND CHOSE NOT TO SEEK MEDICAL TREATMENT. NO FURTHER DETAILS REGARDING THE EVENT WERE AVAILABLE. ABBOTT CUSTOMER SERVICE ADVISED HER TO GO GET AN (B)(6) TEST, AND REPEAT IN 3 MONTHS AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199161 ARCHITECT HIV AG/AB COMBO MZF ABBOTT GERMANY UNKNOWN

    Patients

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