BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 3899804 · Received June 27, 2014

    Report

    Report Number
    1628664-2014-00125
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZV
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WERE NO RETURNS MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND AFTER INSPECTING THE ANALYZER IDENTIFIED THE LIKELY CAUSE OF THE CUSTOMER'S ISSUE TO BE THE INTEGRATED CHIP TECHNOLOGY (ICT) PINCH VALVE TUBING, WHICH WAS WORN FROM NORMAL USE. THE FSE REPLACED THE TUBING. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. 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 CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION AND OBSERVATIONS FROM THE CUSTOMER SITE, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. THE DEVICE PERFORMS AS INTENDED WHEN PROPERLY MAINTAINED AND SAMPLE INTEGRITY/HANDLING IS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS DISCREPANT POTASSIUM ASSAY RESULTS OCCURRING INTERMITTENTLY SINCE (B)(6) 2014 ON THE ARCHITECT C16000 ANALYZER. ONE EXAMPLE WAS PROVIDED: AN INITIAL RESULT OF 6.6 MMOL/L THAT RETESTED AT 4.5 MMOL/L. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376614 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER MZV ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 PINCH TUBING LN: 7-204068-01