BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 6069434 · Received November 1, 2016

    Report

    Report Number
    1628664-2016-00276
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 11, 2016
    Report Date
    April 11, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT INFORMATION; 1. PATIENT IDENTIFIER - THE COMPLETE NUMBER IS - (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED DISCREPANT SODIUM RESULTS ON ARCHITECT C803079. AN ABBOTT REPRESENTATIVE REVIEWED THE ARCHITECT SYSTEM LOGS AND OBSERVED EXCEPTION ERROR 3375 [UNABLE TO PROCESS TEST, ASPIRATION ERROR] OCCURRED ON SID (B)(4). THE ABBOTT REPRESENTATIVE CONSIDERED THE ASPIRATION ERROR TO BE RELATED TO SAMPLE INTEGRITY AND RECOMMENDED REPLACEMENT OF THE SAMPLE PROBE. A REVIEW OF THE C803079 SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING DISCREPANT RESULTS. A REVIEW OF PRODUCT LABELING FOUND THE ARCHITECT SYSTEMS OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND ADDRESSES ERRATIC ICT RESULTS, INCLUDING BUT NOT LIMITED TO: SAMPLE INTEGRITY; IMPROPER SAMPLE COLLECTION AND/OR PREPARATION; AND PROBE INTEGRITY ISSUES. THE SYSTEM OPERATIONS MANUAL ALSO ADDRESSES THE SAMPLE PROBE REMOVAL AND REPLACEMENT; THE PROCEDURE RECOMMENDS REPLACEMENT INTERVALS FOR THE SAMPLE PROBE. A REVIEW OF COMPLAINTS FOR THE ISSUE OF DISCREPANT SODIUM RESULTS FOUND NO SIMILAR ISSUES AND NO TREND WAS ASSOCIATED WITH THE ARCHITECT C8000 FOR ERRATIC RESULTS. BASED ON THE RESULTS OF THE INVESTIGATION, NEITHER A DEFICIENCY NOR A MALFUNCTION OF ARCHITECT C803079 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY INCREASED SODIUM (NA) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) - INITIAL NA-162 / 138 / 139 (RANGE 136-145MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720525 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1