BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2173407 · Received July 23, 2011

    Report

    Report Number
    1628664-2011-00539
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INSTRUMENT LOGS FOUND THAT THE SAMPLE ASPIRATION AND DISPENSE PRESSURE MONITORING (PM) DATA GENERATED BY THE SUSPECT SAMPLE DID NOT LOOK ABNORMAL AND DID NOT EXCEED THE LIMIT REQUIRED TO GENERATE AN ERROR. THE PRE SAMPLE AND POST SAMPLE INTEGRATED CHIP TECHNOLOGY (ICT) REFERENCE SOLUTION (IREF) MILLIVOLT (MV) READINGS OF THE REPEAT RESULT (140) SHOWS A DIFFERENCE OF 2.47 MV, WHICH IS MUCH LARGER THAN THE DIFFERENCES OBSERVED ON THE MAJORITY OF SODIUM RESULTS. THE RESULT LOG SHOWS THE PRE SAMPLE IREF READINGS SHIFTED AND BECAME UNSTABLE WITH THE NEW ICT MODULE. ALSO, THE PRE AND POST SAMPLE IREF DIFFERENCES WITH THE NEW ICT MODULE SHOWED MORE VARIATION THAN THE PREVIOUS ICT MODULE, WHEN SOME DIFFERENCES EXCEEDED 3 MV. THE LARGEST PRE / POST IREF DIFFERENCE WAS -4.097. HOWEVER, AFTER THE ICT O-RINGS WERE CHECKED AND THE ICT MODULE WAS RESEATED THE IREF READINGS SHIFTED BACK AND BECAME MORE STABLE. THIS IREF DATA INDICATES THE ICT MODULE INSTALLATION PROCEDURE MAY HAVE BEEN COMPROMISED, AND CHECKING THE O-RINGS AND RESEATING THE MODULE IMPROVED PERFORMANCE. CONCLUSIONS OF INSTRUMENT LOG REVIEW: BASED ON THE AVAILABLE INFORMATION, THE CUSTOMER'S ISSUES WERE PROBABLY CAUSED BY AN ICT MODULE INSTALLATION ISSUE, SUCH AS TWISTED O-RINGS AND/OR ICT PROBE AND OR TUBING CONNECTION ISSUES. THE AVAILABLE INFORMATION DOES NOT INDICATE THE ISSUES WERE CAUSED BY LOW ICT REFERENCE SOLUTION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN201837-108, JANUARY, 2010) AND THE ICT SAMPLE DILUENT PACKAGE INSERT (304465/ R1, OCTOBER 2009) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE LARGER THAN EXPECTED IREF MV FLUCTUATIONS WAS NOT FOUND. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; INSTRUMENT LOG REVIEW.

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4); INCORRECT OR INADEQUATE RESULT (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POOR ARCHITECT ICT QUALITY CONTROL PERFORMANCE AFTER THE CUSTOMER REPLACED THE ICT MODULE. THE CHLORIDE CALIBRATION FAILED AND THE SODIUM AND POTASSIUM CONTROLS WERE OUT OF RANGE LOW. THE CUSTOMER PERFORMED THE RECOMMENDED TROUBLESHOOTING PROCEDURES AND RECALIBRATION OF THE ICT MODULE WHICH WAS INITIALLY SUCCESSFUL, HOWEVER, LATER THE SAME DAY, THE CUSTOMER OBSERVED CHLORIDE QUALITY CONTROLS OUT OF RANGE AND THE SODIUM AND POTASSIUM WITHIN RANGE BUT AT A 2SD LIMIT. THE CUSTOMER REPLACED THE ICT MODULE AGAIN, BUT DID NOT SEE ANY CHANGE IN CONTROL OR PATIENT RESULTS. THE CUSTOMER BELIEVED THE POOR ICT ASSAY PERFORMANCE WAS DUE TO THE ICT REFERENCE SOLUTION NEAR EMPTY. THREE PATIENT RESULTS GENERATED DURING THIS TIME WERE QUESTIONED BY A PHYSICIAN. AN EXAMPLE OF THE QUESTIONABLE SODIUM RESULTS WAS PROVIDED BY THE CUSTOMER AS FOLLOWS: SAMPLE #1 INITIAL RESULT: 164, REPEAT RESULT: 140, REPEAT AFTER TROUBLESHOOTING: 139 MMOL/L, RESPECTIVELY. THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ICT INT REFERENCE SOLUTION| AERO/C8K ICT MOD LN: 9D28-03| ARCHITECT ICT MODULE| ICT INT REF SOL LN: 01E49-20| CONC ICT DIL LN:02P32-50 LOT:89053HW00