BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8523555 · Received April 17, 2019

    Report

    Report Number
    1628664-2019-00312
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Report Date
    August 15, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ICT DILUENT, LIST NUMBER 2P32, LOT NUMBER 99546UN18 DID NOT FIND ANY SIMILAR COMPLAINTS AND NO TRENDS ASSOCIATED WITH THIS ISSUE WERE IDENTIFIED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE TEXT IN THE TICKET INDICATES THAT TROUBLESHOOTING RESOLVED THE ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ICT DILUENT, LOT NUMBER 99546UN18.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM (NA) RESULTS ON ONE PATIENT ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: PT# 6 = 113 / 117 / 133MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317552 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM| SODIUM