BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 8516683 · Received April 15, 2019

    Report

    Report Number
    1628664-2019-00306
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 23, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT CSC CONFIRMED THE ISSUE BY REVIEWING ABBOTTLINK LOGS. FIELD SERVICE (FS) PERFORMED EXTENSIVE TROUBLESHOOTING ON SEVERAL DATES. FS ACTIONS INCLUDED CLEANING, ADJUSTING, AND/OR REPLACING MULTIPLE PARTS. THE PARTS REPLACED INCLUDE THE ICT MODULE AND PROBE, A BELLOWS SET, A POPPET VALVE SET, 3 ICT CHECK VALVES, FOUR 1 ML SYRINGES, AND THE ICT TUBING WARMER RING. HOWEVER, A SPECIFIC CAUSE WAS NOT IDENTIFIED SO THE INSTRUMENT (B)(4) WAS IDENTIFIED AS THE LIKELY CAUSE. A REVIEW OF THE ARCHITECT (B)(4) SERVICE HISTORY FOUND NO OTHER CONTRIBUTING FACTORS, AND NO ADDITIONAL REPORTS INVOLVING POTASSIUM HAVE BEEN RECEIVED SINCE THE FS SITE VISIT. A 12-MONTH COMPLAINT REVIEW FOR C8000 LIST 1G06 DID NOT IDENTIFY AN ISSUE OR ADVERSE TREND RELATED TO DISCREPANT OR ERRATIC RESULTS. A REVIEW OF THE MONTHLY PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED THAT THE CALCULATED ERRATIC RATES FOR THE ARCHITECT SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT AND NO SYSTEMIC ISSUES OR ADVERSE TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). THE CUSTOMER IDENTIFIED 7 ICT SERIAL NUMBERS FROM 6 LOTS OF ICT MODULES ALLEGED TO HAVE POTASSIUM ISSUES IN THEIR LAB WHICH ARE ASSOCIATED WITH ADDITIONAL TICKETS. THE ICT LOTS ARE 181123, 181120, 180827, 180910, 180713, AND 181130. A SEARCH FOR EACH OF THESE LOTS DID NOT IDENTIFY AN ISSUE OR ADVERSE TREND INVOLVING POTASSIUM RESULTS OR ANY OTHER ISSUE. A 12 MONTH REVIEW OF ICT MODULE (LN 09D28-03) TRACKING AND TRENDING DATA IN REVEALED NO ISSUES OR ADVERSE TRENDS. A SEARCH FOR ICT MODULE NON-CONFORMITIES FOUND NO ITEMS INVOLVING POTASSIUM RESULTS. A REVIEW OF THE CUSTOMER POTASSIUM RELATED TICKETS FINDS SOME WERE NOT CAUSED BY THE ICT MODULE ITSELF. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND C8000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDE ADEQUATE LABELING REGARDING THE ICT MODULE, CUVETTE WASHER, LIMITATIONS OF RESULT INTERPRETATION, MAINTENANCE, COMPONENT REPLACEMENT, AND TROUBLESHOOTING THE REPORTED ISSUE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT OBSERVED FALSE ELEVATED POTASSIUM RESULTS ON APPROXIMATELY 27 PATIENT SAMPLES THAT REPEAT AS EXPECTED WHEN PROCESSING ON THE ARCHITECT C8000. AN EXAMPLE PROVIDED OF A PATIENT THAT TESTED ARCHITECT POTASSIUM OF 6.3, 4.4, 6.7 (ID (B)(6)), 4.5, 4.5 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306900 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1