BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8449665 · Received March 25, 2019

    Report

    Report Number
    1628664-2019-00259
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 29, 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

    THE FIELD SERVICE REPRESENTATIVE INSPECTED THE ANALYZER AND OBSERVED DRIED SPLATTERING ON PARTS OF THE CUVETTE SEGMENTS. THE FSR MANUALLY CLEANED AND INSPECTED ALL ARCHITECT C4 CUVETTE SEGMENTS. THE ARC C4 CUVT SEG (PART NUMBER 02P75-01) WAS CONSIDERED THE LIKELY CAUSE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON C402301 AFTER THE CUVETTE SEGMENTS WERE CLEANED AND INSPECTED. THE ARC C4 CUVT SEG (PART NUMBER 02P75-01) WAS CONSIDERED THE LIKELY CAUSE OF THE DISCREPANT RESULTS. A REVIEW OF THE ARCHITECT SERIAL (B)(4) SERVICE HISTORY IDENTIFIED NO ADDITIONAL CONTRIBUTING FACTORS AND NO SUBSEQUENT DISCREPANT RESULTS HAVE BEEN REPORTED SINCE FIELD SERVICE CLEANED THE CUVETTE SEGMENTS. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE CUVETTE SEGMENTS IDENTIFIED NO ISSUES OR TRENDS. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LIKELY CAUSE PART AND NO ISSUES WERE IDENTIFIED. TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR ALINITY C/CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS RELATED TO THE COMPLAINT ISSUE. THE C4000 ERRATIC RESULT RATE WAS REVIEWED AND IS WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMERS ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 ANALYZER WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT INFORMATION: NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C4000 ANALYZER. SAMPLE ID (B)(6) WAS TESTED MULTIPLE TIMES GENERATING ONE RESULT OF 8.9 MG/DL AND ALL OTHERS WERE 1.7 MG/DL. THE CUSTOMER USES A NORMAL RANGE OF 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241599 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-21| CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-21| LOT 45722UN18| LOT 45722UN18| CLINICAL CHEMISTRY MAGNESIUM, LN 07D70-21| LOT 45722UN18