BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11993192 · Received June 14, 2021

    Report

    Report Number
    3016438761-2021-00214
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INSPECTION, THE FIELD SERVICE REPRESENTATIVE PERFORMED MULTIPLE TROUBLESHOOTING PROCEDURES OF THE ARCHITECT C1600446 AND DETERMINED THE AERO C8K POP VLV (09D36-02) & BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) WERE THE CAUSES OF THE CUSTOMER ISSUE. THESE PARTS WERE REPLACED, WHICH RESOLVED THE CUSTOMER ISSUE. A REVIEW OF THE SERVICE HISTORY FOR THE ARCHITECT C1600446 WAS CONDUCTED AND REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS WERE REPORTED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE AERO C8K POP VLV (09D36-02) OR BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) PARTS. MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO ISSUES WERE IDENTIFIED FOR THE LIKELY CAUSE PARTS. THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C4000 SYSTEMS WERE REVIEWED AND ALL BELOW THE UPPER CONTROL LIMIT; NO SYSTEMIC ISSUES OR TRENDS WERE IDENTIFIED FOR THE ISSUE ASSOCIATED WITH THIS TICKET. LABELING WAS ALSO REVIEWED AND ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND COMPONENT REPLACEMENT OF THE AERO C8K POP VLV (09D36-02), TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS, AS WELL AS REMOVAL AND REPLACEMENT PROCEDURES FOR THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02). BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE AERO C8K POP VLV (09D36-02), BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02), OR THE ARCHITECT C1600446.

    Additional Manufacturer Narrative · 1

    COMPLETE INFORMATION FOR PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2021-00349 UNDER A DIFFERENT SUSPECT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS WERE GENERATED FOR A PATIENT ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER STATED ON 21MAY2021 SID (B)(6) GENERATED AN INITIAL RESULT OF 19.10 MG/DL, WITH A REPEAT RESULT OF 9.33 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891409 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CALCIUM(11440T), 03L79-32, 90569UN20| CC CALCIUM(11440T), 03L79-32, 90569UN20| CC CALCIUM(11440T), (B)(4)