BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 6549593 · Received May 5, 2017

    Report

    Report Number
    1628664-2017-00188
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    June 27, 2016
    Report Date
    May 5, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S INSTRUMENT LOGS WERE REVIEWED AND NOTED MULTIPLE ASPIRATION ERRORS ASSOCIATED WITH THE SAMPLE ID AND TWO OTHER SAMPLE IDS. ADDITIONALLY AROUND THE TIME THE FALSE DEPRESSED RESULT WAS OBTAINED MULTIPLE LOW FLAGS WERE OBTAINED ON OTHER SAMPLES. FURTHER REVIEW OF THE INSTRUMENT MAINTENANCE LOGS FOUND THE ISSUE OCCURRED SHORTLY AFTER PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE INSTRUMENT. IT WAS NOTED THAT AFTER THE PREVENTATIVE MAINTENANCE THE INSTRUMENT LOGS DID NOT INCLUDE DOCUMENTATION OF COMPLETION OF FLUSH WATER LINED, FLUSH ICT MODULE OR FLUSH BULK SOLUTIONS WHICH ARE REQUIRED TO REMOVE ANY AIR THAT MIGHT BE PRESENT. A SEARCH OF COMPLAINTS FOR ICT MODULE LOT 160319 FOUND NO OTHER COMPLAINTS. REVIEW OF COMPLAINT AND TRENDING DATA FOR ICT MODULE IDENTIFIED NO ISSUES OR TRENDS. A REVIEW OF ARCHITECT C4000 TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS RELATED TO THE CURRENT COMPLAINT. THE ARCHITECT C4000 ERRATIC RESULT RATE WAS REVIEWED AND IS WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED SODIUM OF 106 (NO UNIT OF MEASURE PROVIDED) ON A PATIENT SAMPLE PROCESSED ON THE ARCHITECT C4000 ANALYZER THAT REPEATED 141. THE ACCOUNT USES A NORMAL REFERENCE RANGE OF 136 TO 145. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329969 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SODIUM ASSAY