BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2628158 · Received June 25, 2012

    Report

    Report Number
    1628664-2012-00321
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Report Date
    June 15, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE FRONT COVER ON THE ARCHITECT C16000 ANALYZER DOES NOT STAY UPRIGHT BUT FALLS SLOWLY. AN ABBOTT FIELD SERVICE REPRESENTATIVE VISITED THE CUSTOMER SITE AND ADJUSTED THE COUNTER BALANCE HINGES ON THE COVER TO RESOLVE THE ISSUE PER THE INSTRUMENT'S SERVICE AND SUPPORT PROCEDURES. NO RISK TO THE OPERATOR WAS NOTED. NO INJURIES OCCURRED AS A RESULT OF THIS ISSUE. THE INSTRUMENT WAS RETURNED TO FULL SERVICE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-109) AND THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL (201980-110) CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT AVAILABLE INFORMATION, A DEFICIENCY OF THE HINGE ASSEMBLY/ARCHITECT C16000 SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE MAIN LARGE COVER (LID) OF THE ARCHITECT C16000 ANALYZER WILL NO LONGER REMAIN OPEN ON IT'S OWN. THE CUSTOMER STATES THAT THE COVER WILL ALSO OCCASIONALLY FALL SHUT. NO INJURIES HAVE OCCURRED DUE TO THIS ISSUE. A SERVICE CALL HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C16000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 HINGE, TOP FRONT COVER LN: 7-76748-01| HINGE, TOP FRONT COVER LN: 7-76748-01