BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2052249 · Received April 12, 2011

    Report

    Report Number
    1628664-2011-00154
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARCHITECT ICT PRE-AMP BOARD PHOTO COUPLER, LOTS 0834 AND 0840. EVALUATION CONCLUSION: NEW WASHING 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 WASHING 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 CUSTOMER'S ARCHITECT C4000 ANALYZER PER MANDATORY TECHNICAL SERVICE BULLETIN 128-014 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