BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 10304934 · Received July 21, 2020

    Report

    Report Number
    3016438761-2020-00134
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Report Date
    September 1, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AT WHICH TIME HE OBSERVED DEPOSITS ON AND IN THE CUVETTES AND MANUALLY CLEANED THE CUVETTES. IN ADDITION, HE ALSO REPLACED MULTIPLE PARTS. THE FSE DETERMINED THE PUMP, PROBE WASH, 16 (ROHS) (PART NUMBER 7-202557-02) AND THE SEAL, WATER LINE SYRINGE (ROHS) (PART NUMBER 2-89347-02) WERE THE LIKELY CAUSES OF THE DISCREPANT RESULTS AND REPLACED THE PARTS. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF MANUFACTURING DOCUMENTATION AND TRENDING DATA FOR THE PUMP, PROBE WASH, 16 (ROHS) AND THE SEAL, WATER LINE SYRINGE (ROHS) IDENTIFIED NO ISSUES OR TRENDS. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS RELATED TO THE COMPLAINT ISSUE. THE ERRATIC RESULT RATES WERE REVIEWED AND WERE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 ANALYZER WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: MULTIPLE = (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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 REPORTED FALSELY ELEVATED CREATININE RESULTS PROCESSED ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER USES A NORMAL RANGE OF 6 TO 10 MG/L. THE RESULTS PROVIDED WERE: SAMPLE ID (B)(6): 31.5, 7.8 AND 7.7 MG/L WHICH MATCHED THE PREVIOUS RESULT OF 7.6 MG/L. SAMPLE ID (B)(6): 37.3, 6.3 AND 6.4 MG/L WHICH MATCHED THE PREVIOUS RESULT OF 6.1 MG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764518 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER, JJE ABBOTT LABORATORIES (IRVING IA/CC)

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST 08L24-41, LOT UNKNOWN| LIST 08L24-41, LOT UNKNOWN| MULTIGENT ENZYMATIC CREATININE,| MULTIGENT ENZYMATIC CREATININE,