BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 9591172 · Received January 15, 2020

    Report

    Report Number
    1628664-2020-00018
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 31, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT PROVIDED: PT# 2 = 166 / 140. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER REPLACED THE ARCHITECT DRYING TIP WHICH RESOLVED THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6) , AFTER THE DRYING TIP WAS REPLACED. A REVIEW OF THE ARCHITECT (B)(6) INSTRUMENT SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THE DISCREPANT RESULT, NOR DID IT IDENTIFY ANY ADDITIONAL ERRATIC OR DISCREPANT RESULTS REPORTED. A REVIEW OF THE ARCHITECT CLINICAL CHEMISTRY SYSTEMS FOUND ALL ERRATIC RESULTS WERE BELOW THE UPPER CONTROL LIMIT. NO TRENDS OR SIMILAR ISSUES FOR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET WERE IDENTIFIED. A REVIEW OF HISTORICAL DATA FOR THE ARCHITECT DRYING TIP ASSOCIATED WITH THIS COMPLAINT, REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES. A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS, INCLUDING, BUT NOT LIMITED TO THE TROUBLESHOOTING PERFORMED BY THE CUSTOMER. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C4000, SERIAL NUMBER (B)(6) , OR THE ARCHITECT DRYING TIP.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM (NA) RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. (B)(6) SERUM = 160 / 143 / 142; PLASMA = 142 (NORMAL RANGE: 136-145), NO UNITS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55229 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 2P24-01 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1