BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1803123 · Received August 17, 2010

    Report

    Report Number
    1628664-2010-00291
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PROBABLE CAUSES COULD HAVE BEEN DUE TO IMPROPER LOADING OF SAMPLES ON THE INSTRUMENT AND NOT REPLACING THE SAMPLE PROBE IN THE REQUIRED TIMEFRAME. THE SAMPLE PROBE WAS LATER REPLACED ON (B)(6) 2010. REVIEW OF THE MESSAGE HISTORY SHOWED NUMEROUS SAMPLE PIPETTOR ERRORS AT THE TIME OF THE FALSE POSITIVE. THE CUSTOMER REPORTS FEWER ERRORS ARE OCCURRING SINCE REPLACING THE SAMPLE PROBE. THE CUSTOMER SUPPORT SPECIALIST ADVISED THE CUSTOMER THAT SAMPLE TUBES MUST BE PROPERLY CENTRIFUGED AND CHECKED BEFORE LOADING ONTO THE INSTRUMENT. FOLLOW UP REPRODUCIBILITY TESTING WAS ACCEPTABLE. THE CURRENT COMBINED ERRATIC RESULT RATE OF 4.48 OCCURRENCES PER MILLION TESTS FOR ARCHITECT IMMUNOASSAY INSTRUMENTS FALLS BELOW THE ESTABLISHED INTERNAL ABERRANT RESULT RATE FOR I2000SR OF 78 OCCURRENCES PER MILLION TESTS ESTABLISHED AT PRODUCT LAUNCH. NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE ISSUE. NO OTHER COMPLAINTS WERE FOUND FOR ERRATIC COMPLAINTS ON THIS INSTRUMENT. THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS AND PROVIDES INSTRUCTIONS FOR THE PROPER LOADING OF SAMPLES ON THE INSTRUMENT AND REPLACING THE SAMPLE PROBE. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I2000SR ANALYZER HAS GENERATED A FALSE POSITIVE TOXOPLASMOSIS IGG RESULT ON A PATIENT SAMPLE. THE INITIAL RESULT WAS POSITIVE AT 67.6 IU/ML. A SECOND SAMPLE WAS TESTED AND THE RESULT WAS NEGATIVE AT 0.1 IU/ML. THE INITIAL SAMPLE WAS THEN RETESTED AND THE RESULT WAS NEGATIVE AT 0.1 IU/ML. THERE WAS NO ADVERSE 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 TOXOPLASMOSIS REAGENT: LIST 6C19-25, LOT 87859HN00| TOXOPLASMOSIS IGG RGT: L/N 6C19-25, LOT 87859HN00