BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 3060696 · Received April 16, 2013

    Report

    Report Number
    1628664-2013-00097
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 3, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE PROBE ON THE ARCHITECT C16000 WAS REPLACED AS IT HAD BEEN ON THE SYSTEM APPROXIMATELY 9 MONTHS. THE CUVETTE WASHER WAS TIGHTENED AND ADDITIONAL PARTS REPLACED, INCLUDING THE 2 ALKALINE WASH VALVES AS DEPOSITS WERE NOTED ON THEM, AND THE PROBE WASH PUMP BELLOWS AS A CRACK WAS FOUND. A REPRODUCIBILITY RUN FOLLOWING ABBOTT SERVICE WAS ACCEPTABLE. AN ISSUE WITH THE CUVETTE WASHER WAS REPORTED 3 DAYS PRIOR TO THE CURRENT COMPLAINT, HOWEVER, IT CANNOT BE DEFINITIVELY DETERMINED IF THERE IS A DIRECT CONNECTION. THE PROBE, VALVE, AND BELLOWS ARE REPLACED AS PART OF PREVENTIVE MAINTENANCE AND ARE COMMONLY REPLACED TO ADDRESS FLUIDICS AND RESULTS ISSUES; NO ADVERSE TRENDS WERE IDENTIFIED WITH RESPECT TO THE REPLACED PARTS. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED, THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. COMPONENTS ARE INSPECTED AS PART OF ROUTINE MAINTENANCE AS DESCRIBED IN THE OPERATIONS MANUAL, BUT A CRACK IN THE BELLOWS SUGGESTS A MALFUNCTION OCCURRED. TROUBLESHOOTING ASSISTANCE IS ALSO AVAILABLE IN CURRENT LABELING FOR ERRATIC RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED ARCHITECT CALCIUM RESULTS ON A PATIENT SAMPLE THAT REPEATED IN THE NORMAL RANGE. SAMPLE ID: (B)(6), TESTED ARCHITECT CALCIUM RESULT OF 0.64 MMOL/L BUT REPEATED 2.10 MMOL/L (NORMAL RANGE). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163837 ARCHITECT C16000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 96512UN12| LOT 96512UN12| CALCIUM, LIST 03L79-21| CALCIUM, LIST 03L79-21