BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 19012095 · Received April 1, 2024

    Report

    Report Number
    3016438761-2024-00183
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 16, 2024
    Report Date
    April 5, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE SOURCE LAMP (LIST NUMBER 09D45-03) WAS TIGHTENED/ADJUSTED AND WAS DEEMED LIKELY CAUSE FOR THE LOW PATIENT RESULTS. THE MODULE, ARCHITECT C4000 SERIAL # (B)(6), FUNCTION WAS VERIFIED WITH A CONTROL RUN. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR SERIAL (B)(6), AS DESCRIBED IN THIS COMPLAINT. 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 DID NOT REVEAL ANY TRENDS FOR THE ARCHITECT C4000 PROCESSING MODULE OR THE SOURCE LAMP (LIST NUMBER 09D45-03). DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE ARCHITECT C4000 PROCESSING MODULE AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE OR THE SOURCE LAMP (LIST NUMBER 09D45-03) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT SODIUM RESULTS FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT ON (B)(6) 2024 = 107 REPEAT RESULT = 141 MMOL/L. REFERENCE RANGE = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT SODIUM RESULTS FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT ON 16MAR2024 = 107 REPEAT RESULT = 141 MMOL/L REFERENCE RANGE = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362169 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SOURCE LAMP, 09D45-03,| SOURCE LAMP, 09D45-03,