BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2822650 · Received November 7, 2012

    Report

    Report Number
    1628664-2012-00469
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER STATED THE FRONT COVER DOES NOT STAY UP, BUT INSTEAD SLOWLY DESCENDS. NO INJURIES HAVE BEEN REPORTED DUE TO THE FRONT COVER NOT REMAINING UP. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE RETENTION SPRING OF THE COVER LID AND RESOLVED THE ISSUE. THE INSTRUMENT IS PERFORMING AS INTENDED AND NO FURTHER ISSUES HAVE OCCURRED. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FRONT COVER OF AN ARCHITECT C4000 ANALYZER FAILED TO LATCH. THERE WAS NO INJURY TO PERSONNEL REPORTED. THE TENSION IN THE COVER HINGE WAS ADJUSTED TO RESOLVE THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1