BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 9143768 · Received October 2, 2019

    Report

    Report Number
    1628664-2019-00646
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Report Date
    October 21, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLESHOOTING, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF THE HISTORICAL DATA, AND A REVIEW OF PRODUCT LABELING. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED THAT THE CUVETTE WASHER NOZZLES WERE OVERFLOWING THE CUVETTES. THE FSR REPLACED THE TUBING FROM NOZZLE TO WASTE PUMP TO ADDRESS THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON (B)(4) AFTER THE NOZZLE TUBING WAS REPLACED. THE TBG. H.C. NOZZLE A WASTE PART NUMBER 7-203008-02 AND TBG. H.C. NOZZLE B WASTE PART NUMBER 7-203009-02 WERE DETERMINED TO BE THE LIKELY CAUSE FOR THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT RESULTS REPORTED ON (B)(4), NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF THE HISTORICAL DATA DID NO IDENTIFY ANY ADVERSE TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS EVENT IS ALSO BEING REPORTED IN MANUFACTURER REPORT NUMBER 1628664-2019-00645, FOR A SECOND SUSPECT MEDICAL DEVICE, LIST 06L45-41.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE FALSE DECREASED TOTAL BILIRUBIN RESULTS WHEN PROCESSING ON THE ARCHITECT C16000. INITIAL RESULTS RANGED FROM 1.9 TO 38.4 AND RETEST RESULTS RANGED FROM 8 TO 46. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939905 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 54329UQ12| TOTAL BILIRUBIN, LIST 06L45-41