BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 992963 · Received February 8, 2008

    Report

    Report Number
    1628664-2008-00039
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 15, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT C8000 ANALYZER GENERATED A DISCREPANT GLUCOSE RESULT FOR ONE PT SAMPLE. AN INITIAL GLUCOSE RESULT OF 31 MG/DL WAS REPORTED OUTSIDE THE LABORATORY. THE FLOOR HAD PERFORMED A POINT OF CARE (POC) GLUCOSE WHICH GENERATED A GLUCOSE RESULT OF GREATER THAN 500 MG/DL. THE REMAINING SAMPLE VOLUME WAS TOO LOW TO REPEAT AND ANOTHER SAMPLE WAS COLLECTED. THIS SECOND SAMPLE GENERATED A C8000 RESULT OF 640 MG/DL. THE CUSTOMER STATES THAT ALL CONTROLS WERE WITHIN RANGE. THE CUSTOMER PERFORMED A PRECISION RUN USING CONTROLS AND MULTIPLE DILUTIONS. ACEPTABLE RESULTS (MG/DL) WERE GENERATED: 270, 270, 270, UNTIL THE LAST SAMPLE, WHICH WAS 25. THE CUSTOMER STATES THAT NO ERROR MESSAGES WERE GENERATED. ALL MAINTENANCE PROCEDURES HAD BEEN PERFORMED. AN ABBOTT FIELD SERVICE REP (FSR) VERIFIED THAT THE PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED AND THE LLS (LIQUID LEVEL SENSE) WAS WORKING AS INTENDED. THE FIELD SERVICE REP PERFORMED A 10 POINT PRECISION RUN WITH THE FOLLOWING RESULT: 104/104/104/102/103/104/103/104/103/56 MG/DL. FOLLOWING THE LAST RESULT, AN ASPIRATION ERROR 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED) WAS GENERATED, BUT NOT PRIOR TO THE DISCREPANT RESULT. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED. END OF REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT# 54072HW00| CLIN CHEM GLUCOSE LN:3L82-40 LOT: 54072HW00| CLINICAL CHEMISTRY GLUCOSE ASSAY LIST # 3L82-40