BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 8462876 · Received March 28, 2019

    Report

    Report Number
    1628664-2019-00263
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Report Date
    April 18, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    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 · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLE SHOOTING, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF ANALYZER SERVICE HISTORY, A REVIEW OF TRACKING AND TRENDING DATA, AND A REVIEW OF PRODUCT LABELING. THE FIELD SERVICE REPRESENTATIVE NOTICED LOOSE TUBING CONNECTION ON THE AERO C8K 1ML SYRINGE. THE FSR RECONNECTED THE AERO C8K 1ML SYR (09D41-02) WHICH WAS CONSIDERED THE LIKELY CAUSE, AND THE ISSUE WAS RESOLVED. NO CONTRIBUTING FACTORS WERE IDENTIFIED. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO ADVERSE TRENDS WITH REGARD TO DISCREPANT PATIENT RESULTS. TRACKING AND TRENDING DID NOT IDENTIFY ANY SYSTEMIC ISSUES OR ADVERSE TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE DECREASED ICT RESULTS WHEN PROCESSING ON THE ARCHITECT C8000. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: INITIAL RESULT OF 125 AND RETEST OF 132 MMOL/L. WHEN RETESTED A FEW DAYS LATER THE RESULT WAS 112 MMOL/L. ADDITIONAL TESTING OF SODIUM GENERATED RESULTS OF 135, 137, 140, AND 141. PAST SODIUM LEVELS HAVE BEEN 132, 135, AND 136 MMOL/L FOR THIS PATIENT. THE CUSTOMER USES A NORMAL RANGE OF 135 TO 145MMOL/L FOR SODIUM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255679 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1