BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 7068918 · Received November 29, 2017

    Report

    Report Number
    1628664-2017-00455
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 30, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEXT INDICATED THE ISSUE WAS RESOLVED BY REPLACING THE MIXER (ALINITY C- SERIES MIXER, LIST NUMBER 09D59-03) AND R1 REAGENT PROBE (LIST NUMBER 01G47-03) AS WELL AS IMPLEMENTING AN ADDITIONAL SMARTWASH. A REVIEW OF THE ARCHITECT C802360 SERVICE HISTORY DID NOT IDENTIFY ANY CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE WAS NO SUBSEQUENT CONTACT FROM THE CUSTOMER REGARDING ERRATIC/DISCREPANT RESULTS. HISTORICAL QUALITY METRICS WERE REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CALCIUM RESULTS FOR PATIENT SAMPLES WHEN TESTED IMMEDIATELY FOLLOWING THE CRP ASSAY. THREE EXAMPLES WERE PROVIDED. PATIENT #1: INITIAL LOW RESULT OF 34 MG/L RETESTED AT 86 AND 85 MG/L. PATIENT #2: SAMPLE (B)(6) INITIAL LOW RESULT OF 37 MG/L RETESTED AT 88 AND 89 MG/L. PATIENT #3: SAMPLE (B)(6) INITIAL LOW RESULT OF 39 MG/L RETESTED AT 96 AND 97 MG/L. THE CUSTOMER'S NORMAL RANGE IS 84 - 102 MG/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848648 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1