BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2061107 · Received April 18, 2011

    Report

    Report Number
    1628664-2011-00168
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: ARCHITECT ICT PRE-AMP BOARD PHOTO COUPLER, LOTS 0834 AND 0840. (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 ICT PRE-AMP BOARD 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 THE ARCHITECT ICT PRE AMP BOARDS AND REPLACE IF NEEDED.

    Description of Event or Problem · 1

    ABBOTT FIELD SERVICE INSPECTED THE 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