BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1902361 · Received November 18, 2010

    Report

    Report Number
    1628664-2010-00415
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE WAS REQUESTED AND REPLACED THE LEAKING REAGENT PROBE AND SAMPLE PROBE AND CLEANED THE OPTICS AND THE SHUTTER ON THE ANALYZER. CMV-M CONTROLS WERE RUN AND RESULTS WERE WITHIN SPECIFICATIONS. CARRYOVER TESTING WAS PERFORMED AND CARRYOVER WAS NOT EVIDENT IN THE TESTING. COMPLAINT TEXT STATES THE MOST LIKELY CAUSE FOR THE ERRATIC RESULTS WAS A LEAKING REAGENT PROBE. PRODUCT LABELING PROVIDES ADEQUATE INFORMATION CONCERNING ERRATIC/ DISCREPANT RESULTS. COMPLAINT DOCUMENTATION WAS REVIEW AND NO ADVERSE TRENDS WERE IDENTIFIED IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE FOR THE ERRATIC CMV-M RESULTS WAS A LEAKING REAGENT PROBE. A DEFICIENCY OF THE ARCHITECT SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SUSPECT FALSELY REACTIVE RESULT OF 1.5 INDEX WAS GENERATED USING THE ARCHITECT CMV IGM ASSAY. THE REACTIVE RESULT WAS INCONSISTENT WITH A PREVIOUS RESULT AND WHEN THE SAME SAMPLE WAS REPEATED, A NONREACTIVE RESULT OF 0.1 INDEX WAS OBTAINED. THERE WERE NO ADVERSE OUTCOMES REPORTED RELATED TO THIS ISSUE.

    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 ARCHITECT CMV IGM RGT LN 6C16-20 LOT # UNK| ARCHITECT CMV IGM RGT LN 6C16-20 LOT # UNK