BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3111532 · Received May 14, 2013

    Report

    Report Number
    1628664-2013-00126
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE AND FOUND THE ICT REFERENCE SOLUTION CUP WAS CONTAMINATED/DIRTY. FS RESOLVED THE ISSUE BY CLEANING THE ICT REF CUP WITH BLEACH FOLLOWED BY DEIONIZED WATER. A REVIEW OF THE CUSTOMER'S SUBSEQUENT SERVICE HISTORY FOUND NO RECURRENCE OF ICT REF CUP ISSUES AND/OR ICT MODULE RESULT RELATED ISSUES. A 12 MONTH REVIEW OF ICT REF CUP TICKET TRENDING DID NOT IDENTIFY ANY TRENDS. LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT IS ADEQUATE WITH REGARD TO REQUIRED MAINTENANCE, COMPONENT REPLACEMENT, AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. LABELING IN THE C4000 FIELD SERVICE MANUAL IS ADEQUATE WITH REGARD TO CLEANING THE ICT REF CUP AND LIQUID LEVEL SENSE (LLS) ELECTRODES. BASED ON THE AVAILABLE INFORMATION, NO MALFUNCTION OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT C4000 RESULTS WERE GENERATED FOR ONE PATIENT. SODIUM INITIAL RESULT OF 164 MMOL/L RETESTED AT 134 MMOL/L. POTASSIUM INITIAL RESULT OF 5.1 MMOL/L RETESTED AT 3.4 MMOL/L. THE SAMPLE WAS TESTED ON A DIFFERENT ARCHITECT ANALYZER AND RESULTS WERE THE SAME AS THE RETEST RESULTS (EXACT VALUES NOT PROVIDED). THE INITIAL ELEVATED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY BECAUSE THEY DID NOT MATCH PREVIOUS RESULTS (DELTA CHECK FAILURE). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212467 ARCHITECT C4000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE, LIST 09D28-03, SERIAL 121121028| ICT MODULE, LIST 09D28-03, SERIAL 121121028