BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3931747 · Received July 14, 2014

    Report

    Report Number
    1628664-2014-00137
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNS WERE NOT NECESSARY FROM THE CUSTOMER SITE FOR THIS EVALUATION. A REVIEW OF THE INSTRUMENT LOGS VERIFIED THE REPORTED ISSUE; HOWEVER, THE INSTRUMENT LOGS WERE NOT HELPFUL IN DETERMINING A SPECIFIC CAUSE. THE DISCREPANT LOW SODIUM RESULTS WERE GENERATED BY A SINGLE SAMPLE AND THE ISSUE WAS LIMITED TO ONLY THAT ONE SAMPLE. ADDITIONAL REVIEW REVEALED THAT THE ICT MODULE IN USE AT THE TIME (SERIAL NUMBER (B)(4)) HAD EXCEEDED ITS WARRANTY TIME LIMIT. ALTHOUGH THE ICT MODULE HAD EXCEEDED ITS THREE MONTH USE WARRANTY THERE IS NO OTHER INDICATION THAT THE ICT MODULE WAS NOT PERFORMING AS EXPECTED. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE ICT MODULE LOT 140116 SERIES. A SERVICE VISIT BY AN ABBOTT FIELD SERVICE ENGINEER RESOLVED AN ISSUE REGARDING CUVETTE WASHER OVERFLOW. RESOLUTION WAS ACHIEVED WITH NO FURTHER ISSUES REPORTED BY THE CUSTOMER. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE WAS ADDRESSED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    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 REPORTS A FALSELY DEPRESSED SODIUM ASSAY RESULT GENERATED FOR ONE PATIENT SAMPLE TESTED ON AN ARCHITECT C4000 ANALYZER. AN INITIAL SODIUM RESULT OF 110 MMOL/L WAS GENERATED, WHICH WAS BELOW THE CUSTOMER'S CRITICAL VALUE CUT-OFF OF 120 MMOL/L (THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 136 - 145 MMOL/L). THE PATIENT IS SUFFERING FROM A CHRONIC ILLNESS (NOT DISCLOSED BY THE CUSTOMER) AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED ON AN IV REGIME OF NORMAL SALINE. NO ADVERSE IMPACT TO THE PATIENT WAS REPORTED. A NEW SAMPLE WAS COLLECTED AND TESTED AND GENERATED A SODIUM RESULT OF 135 MMOL/L. THE CUSTOMER THEN RETESTED THE INITIAL SAMPLE AND THIS TIME A RESULT OF 123 MMOL/L WAS GENERATED. THE SECOND SAMPLE WAS ALSO RETESTED WITH A VALUE OF 135 MMOL/L. THE FOLLOWING DAY, THE INITIAL SAMPLE WAS TESTED AGAIN AND GENERATED A RESULT OF 135 MMOL/L. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE HAVE BEEN NO ISSUES WITH ANY OTHER PATIENT SAMPLES AND SUBSEQUENT SAMPLES FROM THIS PATIENT HAVE GENERATED NORMAL RESULTS. THE NURSE DID COMMENT THAT THE PATIENT IS A DIFFICULT TO DRAW. THE CUSTOMER EXPRESSED NO DISSATISFACTION WITH THE INSTRUMENT'S PERFORMANCE. THERE IS NO FURTHER IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410514 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT: 140116072| ICT MODULE LN: 09D28-03| ICT MODULE LN: 09D28-03| CUVETTE DRYING TIP LN: 09D51-02| LOT: 140116072