BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2230906 · Received September 1, 2011

    Report

    Report Number
    1628664-2011-00597
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE FRONT PANEL LID OF THE ARCHITECT C4000. THE CUSTOMER STATED EACH MORNING WHEN THE CUSTOMER PERFORMS DAILY MAINTENANCE, THE FRONT PANEL DOES NOT STAY UP ON ITS OWN. THE FSR TIGHTENED THE SCREWS OF THE HINGES OF THE FRONT COVER PANEL AND SEVERAL FOLLOW UPS WITH THE CUSTOMER VERIFIED THE ISSUE IS RESOLVED. A REVIEW OF COMPLAINTS FOUND NO ADDITIONAL COMPLAINTS WHERE PERSONAL INJURY DID OR COULD OCCUR FOR THE FRONT PANEL ISSUE. REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED WHICH STATES MAINTENANCE OR DIAGNOSTIC PROCEDURES EXPOSES THE OPERATORS TO MOVING PARTS THAT CAN POTENTIALLY CAUSE PERSONAL INJURY. NO PRODUCT DEFICIENCY WAS DETERMINED IN THE COMPLAINT EVALUATION.

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT. MIGRATION OF DEVICE OR DEVICE COMPONENT. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    ABBOTT TECHNICAL AREA SERVICE REPRESENTATIVE CONTACTED ABBOTT REGARDING THE CUSTOMER'S ARCHITECT C4000 ANALYZER. WHEN THE CUSTOMER PERFORMS ANALYZER MAINTENANCE, THE PROCESSING MODULE COVER DOES NOT ADEQUATELY STAY UP. ONCE THE COVER IS OPENED, IT SLOWLY DESCENDS AND COMES TO REST ON THE CUSTOMER'S HEAD. FIELD SERVICE WAS DISPATCHED TO THE CUSTOMER SITE TO REPLACE THE HINGES AND SPRINGS THAT SUPPORT THE ANALYZER'S PROCESSING MODULE COVER. THE FIELD SERVICE REPRESENTATIVE EVALUATED THE ISSUE AND TIGHTENED THE PROCESSING COVER HARDWARE. THERE WAS NO INJURY ASSOCIATED WITH THE CUSTOMER'S ANALYZER, AND NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1