BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 1872803 · Received October 18, 2010

    Report

    Report Number
    1628664-2010-00380
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROBABLE CAUSES INCLUDE ISSUES WITH THE ICT MODULE AND/OR THE ICT PROBE AND/OR THE 1ML SYRINGE AND/OR THE ICT REFERENCE CHECK VALVE WHICH WERE ALL REPLACED BY ABBOTT FIELD SERVICE AS A PRECAUTION TO ADDRESS THE ISSUE. ABBOTT FIELD SERVICE ADDRESSED THE ISSUE BY REPLACING THE FOLLOWING 4 ITEMS AS A PRECAUTION; 1 ML SYRINGE (LN 09D41-02), ICT REFERENCE CHECK VALVE (LN 09D35-02), ICT PROBE (LN 09D63-03), AND THE ICT MODULE (LN 09D28-03). THE SYSTEM LOGS FROM ARCHITECT (B)(4) VERIFY THE ISSUE BUT DO NOT REVEAL ANY EVIDENCE SUPPORTING A DEFINITIVE PROBABLE CAUSE FOR THE DISCREPANT RESULTS. ONE OF THE SUSPECT SAMPLES RESULTS REVEALED MILLIVOLT (MV) FLUCTUATIONS BETWEEN THE PRE AND POST SAMPLE IREF READS, BUT THE FLUCTUATIONS DID NOT EXCEED THE LIMIT OF 10MV, THEREFORE NO ERROR WAS GENERATED. (B)(4). IREF MV FLUCTUATIONS MAY BE CAUSED BY ICT MODULE ISSUES, FLUIDICS ISSUES, OR OTHER UNKNOWN FACTORS. A SPECIFIC CAUSE IS NOT IDENTIFIED IN (B)(4). A REVIEW OF THE COMPLAINT HISTORY FOR (B)(4) FINDS NO RECURRENCE OF ERRATIC ICT RESULTS OR ANY EVIDENCE SUPPORTING A CAUSE FOR THE ERRATIC RESULTS ON (B)(6) 2010. A REVIEW OF C16000 COMPLAINT AND TRENDING DATA DID NOT IDENTIFY ANY ADVERSE TREND OR PRODUCT ISSUE RELATED TO THE ICT MODULE, ICT PROBE, ICT REFERENCE CHECK VALVE, OR 1 ML SYRINGE. THE CURRENT RATE OF INCONSISTENT, ERRATIC, AND ABERRANT COMPLAINTS AND OCCURRENCES IS BELOW THE ESTABLISHED LIMITS FOR THE ARCHITECT CLINICAL CHEMISTRY SYSTEMS. LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT PROVIDE SUFFICIENT INFORMATION WITH REGARD TO C16000 USE AND MAINTENANCE, COMPONENT REPLACEMENT, CALIBRATION AND CONTROL REQUIREMENTS, AND TROUBLE SHOOTING THE CUSTOMERS ISSUE. PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE CUSTOMERS ISSUE ARE PROVIDED UNDER THE OBSERVED PROBLEMS ERRATIC RESULTS, POOR PRECISION. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE ISSUE WAS NOT IDENTIFIED. PROBABLE CAUSES INCLUDE ISSUES WITH THE ICT MODULE AND/OR THE ICT PROBE AND/OR THE 1ML SYRINGE AND/OR THE ICT REFERENCE CHECK VALVE WHICH WERE ALL REPLACED BY ABBOTT FIELD SERVICE AS A PRECAUTION TO ADDRESS THE ISSUE. THE EVALUATION DID NOT IDENTIFY A DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C16000K ANALYZER HAS GENERATED DISCREPANT (B)(6) RESULTS ON (B)(6) PATIENT SAMPLES. THE ACCOUNT STATED THE INITIAL RESULTS WERE CRITICAL RESULTS, BUT WHEN RETESTED THE RESULTS WERE IN THE NORMAL RANGE. THE SAMPLES WERE TESTED ON FOUR DIFFERENT ARCHITECT ANALYZERS. THE ACCOUNT PROVIDED THE FOLLOWING RESULTS FOR PATIENT (B)(6); UNITS OF MEASUREMENT IS MMOL/L. INITIAL RESULT, RETEST RESULT'S), NA 123, 144; K 3.3, 3.8; CL 129, 108, 109, 110, THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT SOLUTION LIST 1E49-20 LOT 40103UN01| ICT SOLUTION LIST 1E49-20 LOT 40103UN01