BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 4746125 · Received May 4, 2015

    Report

    Report Number
    1628664-2015-00144
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 9, 2015
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VERBIAGE FROM ICT CONCENTRATED DILUENT TO ICT SAMPLE DILUENT. A REVIEW OF THE PRODUCT LABELING, HISTORICAL COMPLAINTS AND MANUFACTURING DOCUMENTATION WAS PERFORMED. HISTORICALLY, THERE ARE NO OTHER COMPLAINTS AGAINST ICT SAMPLE DILUENT LOT 27935UN14. THE TRENDING REPORTS REVIEWED DO NOT IDENTIFY AN ADVERSE OR NON-STATISTICAL TREND FOR THIS PRODUCT. REVIEW OF PRODUCT LABELING REVEALED ADEQUATE LABELING FOR THE HANDLING OF REAGENTS, SAMPLES, INTERPRETATION OF ASSAY RESULTS, AND TROUBLESHOOTING THIS COMPLAINT ISSUE. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. THE EVALUATION DETERMINED THE ARCHITECT C4000 AND ICT SAMPLE DILUENT IS PERFORMING ACCEPTABLY.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED SODIUM RESULTS ON 2 PATIENTS PROCESSED ON THE ARCHITECT C4000 ANALYZER THAT REPEATED HIGH. THE ACCOUNT USES A NORMAL SODIUM REFERENCE RANGE OF 136 TO 145 MMOL/L. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: ID (B)(6) GENERATED SODIUM OF 105, 102, 101, 100 MMOL/L BUT AFTER CALIBRATION REPEATED AT 146 MMOL/L. PATIENT 2 GENERATED SODIUM <100 MMOL/L BUT AFTER CALIBRATION REPEATED AT 146 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290246 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT CONCENTRATED DILUENT LIST 02P32-11| LOT 27935UN14