BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 6634876 · Received June 12, 2017

    Report

    Report Number
    1628664-2017-00253
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Report Date
    August 30, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Removal / Correction Number
    1628664-07/17/18-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. A MALFUNCTION OF THE SAMPLE PROBE 01G48-04 WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A PATIENT IN RENAL FAILURE: SID (B)(6), NA+ INITIAL <100 REPEAT 144, <100, 142. CL- INITIAL 57 REPEAT 106, 105. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415912 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1