BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8910213 · Received August 20, 2019

    Report

    Report Number
    1628664-2019-00570
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY COMPLAINTS THAT WERE SIMILAR FOR FALSELY DEPRESSED ELECTROLYTE PATIENT RESULTS. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO TRENDS RELATED TO THIS ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: COMPLETE SID'S: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM (NA) RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: SID (B)(6), (B)(6) 2019; NA = 111 MEQ/L. REDREW SAMPLE 2 HRS LATER SID (B)(6): NA = 141MEQ/L. RE-RAN ORIGINAL SAMPLE: NA = 141MEQ/L. 3RD REDRAWN SAMPLE: NA = 141 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706291 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1