BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2560647 · Received May 4, 2012

    Report

    Report Number
    1628664-2012-00271
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 12, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICT MODULE WAS REPLACED ON THE ARCHITECT C8000 AND AN ANNUAL PREVENTIVE MAINTENANCE WAS PERFORMED WHICH RESOLVED THE ISSUE. REVIEW OF QUALITY METRICS FOUND NO ATYPICAL COMPLAINT ACTIVITY THAT COULD BE RELATED TO THE DESCRIBED CUSTOMER ISSUE AND NO ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH DISCREPANT NA+, K+, CL- RESULTS WERE IDENTIFIED. REVIEW OF THE PRODUCT LABELING REVEALED THAT THE ISSUE IN QUESTION IS ADEQUATELY ADDRESSED IN THE LABELING CLAIMS. BASED UPON 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ERRATIC RESULTS WERE GENERATED ON THE ARCHITECT C8000 ANALYZER ON (B)(6) 2012. THE CUSTOMER PROVIDED ONE EXAMPLE OF PATIENT RESULTS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SAMPLE ID (B)(6) INITIAL RESULTS: SODIUM 120 MMOL/L; CHLORIDE 121 MMOL/L; POTASSIUM 3.2 MMOL/L . SAMPLE ID (B)(6) REPEAT RESULTS: SODIUM 141, 139 AND 139 MMOL/L; CHLORIDE 99, 100 AND 99 MMOL/L; POTASSIUM 3.7, 3.7 AND 3.7 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE LIST 09D28-03, SERIAL UNKNOWN| ICT MODULE LIST 09D28-03, SERIAL UNKNOWN