BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2031902 · Received March 28, 2011

    Report

    Report Number
    1628664-2011-00129
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEW (B)(4) PROCESS IMPACTED THE LONG TERM RELIABILITY OF THE PHOTO COUPLERS WHICH DEGRADE SLOWLY OVER TIME. THE CAUSE OF THE ARCHITECT ANALYZER PHOTO COUPLER DEGRADATION ISSUE WAS DUE TO A NEW MANUFACTURING (B)(4) PROCESS IMPLEMENTED BY THE SUPPLIER. ABBOTT ISSUED A PRODUCT CORRECTION LETTER TO ALL CUSTOMERS WITH AFFECTED INSTRUMENT SERIAL NUMBERS AND IMPLEMENTED A MANDATORY TECHNICAL SERVICE BULLETIN TO INSPECT ICT PRE AMP BOARDS AND REPLACE IF NEEDED.

    Description of Event or Problem · 1

    ABBOTT FIELD SERVICE INSPECTED THE CUSTOMER'S ARCHITECT C4000 ANALYZER PER MANDATORY TECHNICAL SERVICE BULLETIN (B)(4) AND REPLACED THE ARCHITECT ICT PRE-AMP BOARD AS REQUIRED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC. C4000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ICT PRE-AMP BOARD PHOTO COUPLER