BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1934310 · Received December 21, 2010

    Report

    Report Number
    1628664-2010-00497
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. THE EVALUATION INCLUDED A REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, A REVIEW OF THIS INSTRUMENT ((B)(4)) SERVICE HISTORY, A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL AND A REVIEW OF THE ARCHITECT CMV IGG AVIDITY ASSAY PACKAGE INSERT. NO SPECIFIC CAUSE WAS IDENTIFIED BEHIND THIS ISSUE. HOWEVER, REVIEWING THE QUALITY CONTROLS REPORTS REVEALED THAT THE QUALITY CONTROL LEVEL NAMED CONT 1 HAD 2 RESULTS THAT WERE FLAGGED WITH THE (B)(6). THE OPERATIONS MANUAL LISTED MULTIPLE CAUSES ALONG WITH THE CORRECTIVE ACTIONS FOR ERRATIC ASSAY RESULTS. NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THIS ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW SHOWED THAT A SUBSEQUENT VISIT BY THE FIELD SERVICE ADDRESSED THE ISSUE AND ENDED UP WITH THE FIELD SERVICE REPLACING SEVERAL INSTRUMENT HARDWARE COMPONENTS INCLUDING THE SAMPLE, STAT, REAGENT 1 AND REAGENT 2 PROBES. NO PRODUCT DEFICIENCY WAS IDENTIFIED BEHIND THIS ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A DISCREPANT RESULT FOR THE ARCHITECT CMV-IGG AVIDITY INDEX. A RESULT OF 66.2% WAS REPEATED AT 31% USING A DIFFERENT NON-ABBOTT METHOD (VIDAS). THE PATIENT WAS RETESTED FOR THE CMV AVIDITY ON THE ARCHITECT ANALYZER WITH A RESULT OF 66.6%. THE PATIENT WAS THEN TESTED FOR THE ARCHITECT CMV-IGM WITH A RESULT OF 14.71 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CMV IGG AVIDITY| CMV IGG AVIDITY