BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 4093995 · Received September 16, 2014

    Report

    Report Number
    1628664-2014-00204
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER DID NOT CONTAIN ENOUGH SPACES FOR ENTIRE PATIENT ID. THE ENTIRE PATIENT ID IS (B)(6). (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE CLEANED THE CUVETTE WASHER AND MANUALLY CLEANED CUVETTES ON THE ARCHITECT C8000 ANALYZER FOR RESOLUTION. NO ADDITIONAL DISCREPANT MAGNESIUM RESULTS WERE REPORTED AFTER THE FIELD SERVICE REPRESENTATIVE VISIT. THE CUVETTE SEGMENTS AND THE CUVETTE WASHER WHICH ARE STILL FUNCTIONAL AT THE CUSTOMER SITE AND ARE NOT AVAILABLE FOR RETURN. A REVIEW OF HISTORICAL DATA REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS ASSOCIATED WITH THE ISSUE DESCRIBED IN THIS COMPLAINT. THE ARCHITECT LABELING PROVIDES ADEQUATE INFORMATION FOR TROUBLESHOOTING THE ISSUE. NO DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY ELEVATED MAGNESIUM OF 7.5 MG/DL PROCESSED ON THE ARCHITECT C8000 ANALYZER. THE SAMPLE WAS REPEATED WITH MAGNESIUM OF 2.3 MG/DL ON THE SAME ANALYZER AND 2.3 MG/DL ON ANOTHER ARCHITECT C8000 ANALYZER. THE PREVIOUS DAY, THE PATIENT TESTED MAGNESIUM OF 2.3 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571174 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 26125UN14| MAGNESIUM LIST 07D70-31