BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 7857288 · Received September 7, 2018

    Report

    Report Number
    1628664-2018-01848
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    June 7, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1628664-07/17/18-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION. PATIENT IDENTIFIER- MULTIPLE = (B)(6). A PRODUCT CORRECTION LETTER WAS ISSUED TO ALL ARCHITECT CLINICAL CHEMISTRY CUSTOMERS NOTIFYING THEM TO ADHERE TO THE LABELING INSTRUCTIONS LISTED IN THE ARCHITECT OPERATIONS MANUAL, SECTION 10, TO RESOLVE ERROR CODES 3580 TO 3585 OR 5381 BEFORE TRANSITIONING THE ARCHITECT TO THE RUNNING STATUS. THE PRODUCT CORRECTION LETTER PROVIDES GUIDANCE ON HOW THE CUSTOMER CAN ENSURE THE PRESSURE MONITORING SYSTEM IS FUNCTIONING AND ALSO RECOMMENDS FOLLOWING THE ARCHITECT SYSTEMS OPERATIONS MANUAL AND THE ASSAY-SPECIFIC DOCUMENTATION TO ENSURE ALL SAMPLES AND REAGENTS MEET DESCRIBED REQUIREMENTS BEFORE BEING PLACED ON THE ARCHITECT. THE INVESTIGATION FOUND THAT WHEN THE PRESSURE MONITOR BOARD COMMUNICATION ON THE ARCHITECT CLINICAL CHEMISTRY ANALYZER IS NOT SUCCESSFULLY ESTABLISHED DURING INITIAL INSTRUMENT BOOT UP, AND THE FOLLOWING ERROR CODES 3580 TO 3585 OR 5381 ARE NOT RESOLVED BY THE USER PRIOR TO TRANSITIONING THE ARCHITECT TO THE RUNNING STATUS, THERE IS THE POTENTIAL TO GENERATE INCORRECT RESULTS AS THE PRESSURE MONITORING SYSTEM IS INACTIVE. THE ARCHITECT SYSTEM SOFTWARE WILL BE UPDATED IN A FUTURE VERSION TO PREVENT THE ARCHITECT ANALYZER FROM TRANSITIONING TO THE RUNNING STATUS WHEN THE PRESSURE MONITORING SYSTEM IS IN AN ERROR STATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCONSISTENT/FALSELY ELEVATED SODIUM RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED: ON 07 JUN 2018 (B)(6): 142, 136, 143 AND 144 MMOL/L; ON 12 JUN 2018 (B)(6): 139, 143, 142, 142 MMOL/L; (B)(6): 143, 138, 136 AND 137 MMOL/L; AND ON 13 JUN 2018 (B)(6): 139, 134, 139, 138 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697820 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1