BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2200167 · Received August 10, 2011

    Report

    Report Number
    1628664-2011-00563
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    August 6, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE ABBOTT FIELD SERVICE ENGINEER REPLACED THE SYRINGE VALVE AND LLS RV1/2 ANTENNA BOARD TO RETURN THE INSTRUMENT TO SPECIFICATIONS. NO ADVERSE TRENDS WERE IDENTIFIED IN CONJUNCTION WITH THE ISSUE OF AN ODOR BEING EMITTED FROM THE I2000. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE.

    Additional Manufacturer Narrative · 1

    (B)(4), NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4), BURN OF DEVICE OR DEVICE COMPONENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER SMELLED A BURNING ODOR FROM THE SAMPLE/R1 SYRINGE AREA ON AN ARCHITECT I2000 ANALYZER. AN ABBOTT FIELD SERVICE ENGINEER (FSE) FOUND FLUID ON THE PROCESSING AREA. THE FSE ALSO FOUND EVIDENCE OF BURNING ON THE RV1 AND RV2 ANTENNA. THE FSE ATTRIBUTED THE FOUND FLUID AND THE EVIDENCE OF BURNING TO SPLASHING FROM THE R1 PIPETTOR SYRINGE. THE R1 PIPETTOR SYRINGE VALVE AND RV1 AND RV2 ANTENNA WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO HARM TO PERSONNEL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1