BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 19807678 · Received July 23, 2024

    Report

    Report Number
    3016438761-2024-00418
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 6, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED EXTENSIVE TROUBLESHOOTING TO RESOLVE THE ISSUE INCLUDING REPLACEMENT OF THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) WAS DETERMINED THE LIKELY CAUSE OF THE RESULT ISSUES DUE TO PART BEING MISALIGNED AND LEAKING. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C4000 MODULE AND THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 MODULE OR THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM, AND CREATININE RESULTS FOR ONE PATIENT ON THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6). THE CUSTOMER REPEATED THE SAMPLE WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL CREATININE RESULT = 0.61 REPEAT RESULT = 2.91 MG/DL REFERENCE RANGE = 0.52-1.04. INITIAL CALCIUM RESULT = 2.6 REPEAT RESULT = 8.8 MG/DL REFERENCE RANGE = 8.4-10.2. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM, AND CREATININE RESULTS FOR ONE PATIENT ON THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6). THE CUSTOMER REPEATED THE SAMPLE WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL CREATININE RESULT = 0.61 REPEAT RESULT = 2.91 MG/DL REFERENCE RANGE = 0.52-1.04 INITIAL CALCIUM RESULT = 2.6 REPEAT RESULT = 8.8 MG/DL REFERENCE RANGE = 8.4-10.2 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935099 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BELLOWS, BELLOWS ONLY (ROHS), 2-89054-02, UNKNOWN| BELLOWS, BELLOWS ONLY (ROHS), 2-89054-02, UNKNOWN