BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2375160 · Received December 15, 2011

    Report

    Report Number
    1628664-2011-00737
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    December 1, 2011
    Report Date
    November 30, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EXPERIENCED ERRATIC SODIUM (NA) RESULTS WITH AN ARCHITECT ICT MODULE LOT 110901 ON THE ARCHITECT C4000 ANALYZER. THE CUSTOMER REPORTED A SINGLE PATIENT SAMPLE GENERATED AN INITIAL DISCREPANT LOW NA RESULT FLAGGED <100, AND AN AUTO-REPEAT RESULT OF 144. THE CUSTOMER REPLACED THE SUSPECT ICT MODULE AND THE NA SLOPE INCREASED TO 98 WITH QC IN RANGE. THE NA SLOPE WAS ON THE LOWER SIDE OF THE ACCEPTABLE SLOPE RANGE LIMITS OF 45 TO 120. TROUBLESHOOTING INCLUDED INSPECTION OF CONNECTIONS ON THE 1 ML SYRINGES, REMOVAL OF THE ICT MODULE AND VERIFYING O-RING PLACEMENT, REPLACEMENT OF THE ICT PROBE, FLUSH OF THE ICT MODULE AND RECALIBRATING THE ICT ASSAYS. THE NA SLOPE INCREASED SLIGHTLY TO 69.8 AND THE NA QUALITY CONTROL WAS ON THE MEAN. THE CUSTOMER ALSO REPORTED ERROR CODE 5618 ICT MEASUREMENT FAILURES OCCURRING INTERMITTENTLY AND REQUESTED FIELD SERVICE ADDRESS THE ISSUE. A COMPLAINT REVIEW DID NOT IDENTIFY ADDITIONAL COMPLAINTS OR TRENDS AGAINST ICT MODULE LOT 110901. COMPLAINTS WERE RESOLVED BY PERFORMING ROUTINE TROUBLESHOOTING PER APPROVED PROCEDURES. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT REVEALED ADEQUATE LABELING WITH REGARD TO REMOVING AND INSTALLING THE ICT MODULE AND ICT PROBE AND TROUBLESHOOTING THE CUSTOMER ISSUE. A SPECIFIC CAUSE FOR THE CUSTOMER ISSUE COULD NOT BE DETERMINED AND DEFICIENCY OF THE ICT MODULE AND/OR ICT PROBE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ERRATIC CLINICAL CHEMISTRY SODIUM RESULTS AFTER THE CUSTOMER RECENTLY REPLACED THE INTEGRATED CHIP TECHNOLOGY (ICT) MODULE. THE CUSTOMER WAS ASKED TO PERFORM TROUBLESHOOTING OF THE ICT MODULE AND RE-RUN THE ICT CALIBRATORS. AFTER THE CUSTOMER PERFORMED THE TROUBLESHOOTING PROCEDURES, THE SODIUM QUALITY CONTROLS WERE ON THE MEAN, HOWEVER, THE CUSTOMER WAS CONCERNED THE ICT MODULE WOULD NOT LAST THREE MONTHS. ADDITIONALLY, THE ANALYZER GENERATED INTERMITTENT ERROR MESSAGE 5618 (ICT MEASUREMENT FAILURE FOR X), THEREFORE THE CUSTOMER REQUESTED SERVICE. FIELD SERVICE PROVIDED THE CUSTOMER WITH A NEW ICT MODULE AND THE SODIUM SLOPE AND QUALITY CONTROLS WERE WITHIN RANGE. THE CUSTOMER PROVIDED ONE QUESTIONABLE SODIUM PATIENT RESULT AS FOLLOWS: INITIAL RESULT = <100 MMOL/L, AUTOREPEAT RESULT = 144 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE DISCREPANT SODIUM RESULT WAS NOT REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 ANALYZER JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY ICT PROBE, LIST # 9D63-03| CLINICAL CHEMISTRY ICT MODULE, LIST # 9D28-03| CLINICAL CHEMISTRY ICT MODULE, LIST # 9D28-03| CLINICAL CHEMISTRY ICTPROBE, LIST # 9D63-03