BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3923672 · Received July 9, 2014

    Report

    Report Number
    1628664-2014-00135
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ICT MODULE 131217027 WAS NOT AVAILABLE FOR RETURN. THE ARCHITECT C803079 INSTRUMENT LOGS VERIFY THE ISSUE. THE ICT REFERENCE SOLUTION MILLIVOLT (MV) DATA SHOWS THE SUSPECT SAMPLE HAS A LINGERING EFFECT ON THE SODIUM MEMBRANE. NO OTHER COMPLAINTS AGAINST ICT 131217027 HAVE BEEN RECEIVED. A REVIEW OF COMPLAINT TRACKING AND TRENDING FOR ICT MODULE LN 09D28-03 DID NOT IDENTIFY A PRODUCT ISSUE OR ADVERSE TREND. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT PROVIDE ADEQUATE INFORMATION WITH REGARD TO TROUBLESHOOTING THE REPORTED ISSUE. THE AVAILABLE INFORMATION INDICATES THE SODIUM MEMBRANE OF ICT MODULE 131217027 HAD BEEN EXPOSED TO AGING AND AN UNKNOWN CONTAMINANT WHICH INTERACTS WITH AN INTERFERENT/CONTAMINANT UNIQUE TO SAMPLES FROM THE PATIENT IN QUESTION. THE ISSUE WAS RESOLVED BY INSTALLING A DIFFERENT ICT MODULE OR TESTING THE SAMPLES ON A DIFFERENT ICT MODULE. A MALFUNCTION IS NOT INDICATED AS THE ICT MODULE PERFORMS AS INTENDED WHEN NOT CONTAMINATED. BASED ON THE INVESTIGATION PERFORMED, A DEFICIENCY IS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ARCHITECT SODIUM RESULT OF 118 MMOL/L WAS GENERATED FOR A PATIENT WITH HISTORY OF 140 MMOL/L RESULTS. THE SAMPLE WAS RETESTED AFTER REPLACING THE ICT MODULE AND THE RESULT WAS 140 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399536 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE, LIST 09D28-03, SERIAL (B)(4)