BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1932714 · Received December 20, 2010

    Report

    Report Number
    1628664-2010-00490
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S OBSERVATION. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND A REVIEW OF THE INSTRUMENT SERVICE HISTORY. THE COMPLAINT TEXT INDICATED FALSE POSITIVE TOXO IGG RESULTS WERE GENERATED ON THE ARCHITECT ANALYZER. THROUGH TROUBLESHOOTING, A FLUID DRIP WAS NOTICED ON THE RACK BELOW THE SAMPLE PROBE. THE PROBE WAS CLEANED AND RECALIBRATED. NO FURTHER ISSUES WERE REPORTED. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS PROBABLE CAUSES AND CORRECTIONS FOR ERRATIC RESULTS. A REVIEW OF THE COMPLAINT TREND REPORTS FOR THE PERIOD OF (B)(4) 2009 TO (B)(4) 2010, INDICATED THERE WERE NO ADVERSE TRENDS ASSOCIATED WITH THE ISSUE UNDER EVALUATION. A REVIEW OF THE SERVICE HISTORY FOR THE ARCHITECT ANALYZER, (B)(4), FROM (B)(4) 2009 TO (B)(4) 2011 INDICATED OTHER INCIDENTS HAD OCCURRED; HOWEVER, THEY WERE RESOLVED THROUGH COMPONENT REPLACEMENT, INSTRUMENT TROUBLESHOOTING OR ADDITIONAL CUSTOMER TRAINING. BASED UPON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE ARCHITECT ANALYZER, LIST NUMBER 3M74-01, (B)(4) IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE REACTIVE ARCHITECT TOXO IGG RESULT WAS GENERATED FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND GENERATED A NON-REACTIVE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH TOXO IGG| ARCH TOXO IGG, (B)(4)