BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 SYSTEM

    MDR report key: 7736773 · Received July 31, 2018

    Report

    Report Number
    1628664-2018-00263
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 12, 2017
    Report Date
    July 31, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Removal / Correction Number
    1628664-07/17/18-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ARCHITECT C8000 SYSTEM, LIST 01G06; PMA/510 K = K 980367. ARCHITECT C16000 SYSTEM, LIST 03L77; PMA/510K = EXEMPT. A PRODUCT CORRECTION LETTER WAS ISSUED ON 17JUL2018 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 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 INTO THIS MATTER 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

    ABBOTT HAS IDENTIFIED THAT CUSTOMERS WHO FAIL TO FOLLOW LABELLING INSTRUCTIONS CAN OVERRIDE ERROR MESSAGES RELATED TO INOPERABLE PRESSURE MONITORING, LEADING TO THE POSSIBILITY OF ERRONEOUS RESULTS. IF PRESSURE MONITORING IS NOT COMMUNICATING PROPERLY DURING POWER UP, THE SYSTEM WILL GENERATE THE FOLLOWING ERROR CODES 3580 TO 3585 OR 5381. THE ARCHITECT OPERATIONS MANUAL, SECTION 10, PROVIDES INSTRUCTIONS ON HOW TO CORRECTLY RESOLVE THESE ERRORS. IF THE ARCHITECT IS TRANSITIONED TO THE RUNNING STATUS WITHOUT SUCCESSFULLY RESOLVING ERROR CODES 3580 TO 3585 OR 5381, THERE IS THE POTENTIAL TO GENERATE INCORRECT RESULTS AS THE PRESSURE MONITORING SYSTEM IS INACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576972 ARCHITECT C4000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1