BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 4201182 · Received October 27, 2014

    Report

    Report Number
    1628664-2014-00228
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING WAS PERFORMED BY THE CUSTOMER AND ALSO BY ABBOTT FIELD SERVICE ON SITE. MULTIPLE PARTS WERE INSPECTED, ADJUSTED AND REPLACED, INCLUDING THE ICT MODULE. A SPECIFIC SINGULAR CAUSE FOR THE DISCREPANT LOW SODIUM RESULTS WAS NOT IDENTIFIED. THE ARCHITECT C8000 SERIAL (B)(4) INSTRUMENT LOGS VERIFY DISCREPANT LOW SODIUM RESULTS WERE GENERATED BUT THE LOGS WERE NOT HELPFUL IN DETERMINING A SPECIFIC CAUSE. THE RESULT LOG DATA REVIEWED DURING THE EVENT TIMEFRAME DID NOT INCLUDE A SODIUM RESULT OF 100 REPEATING AT 140 MMOL/L. THE ICT MODULE WAS NOT AVAILABLE FOR RETURN. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR ICT LOT 140606. A 12 MONTH REVIEW OF TRACKING AND TRENDING FOR ICT MODULE 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. POSSIBLE CAUSES THAT COULD NOT BE COMPLETELY RULED OUT INCLUDE SAMPLE INTEGRITY OR HANDLING ISSUES, DIRTY CUVETTES, ICT MODULE CONTAMINATION, LOOSE CONNECTIONS OF THE ICT MODULE PROBE AND/OR TUBING, OR ISSUES WITH OTHER FLUIDIC COMPONENTS WHICH WERE SERVICED DURING TROUBLESHOOTING. NO MALFUNCTION OR DEFICIENCY WAS IDENTIFIED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A DEPRESSED SODIUM OF APPROXIMATELY 100 MMOL/L ON A PATIENT SAMPLE PROCESSED ON THE ARCHITECT C8000 ANALYZER. THE SAMPLE WAS REPEATED WITH A SODIUM OF 140 MMOL/L WHICH IS THE CORRECT RESULT FOR THE PATIENT. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681634 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM LIST 2P32| SODIUM LIST 2P32