BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3677744 · Received March 13, 2014

    Report

    Report Number
    1628664-2014-00046
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Report Date
    February 24, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ARCHITECT C8000 ANALYZER (C800412) RESULT LOG WAS REVIEWED. NO LOW K RESULTS RETESTING AS NORMAL WERE NOTED. THE LOWEST K RESULT WAS 2.7 AND RETESTING GENERATED CONSISTENT RESULTS. THE K PRE AND POST ICT REFERENCE SOLUTION MILLIVOLT DATA APPEARED STABLE WITH LOW DELTA VALUES RANGING BETWEEN -0.60 TO 1.50. THE K CALIBRATION SLOPES APPEARED STABLE IN THE LOW 90S WHICH IS WITHIN ACCEPTABLE LIMITS. A SPECIFIC CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. SAMPLE INTEGRITY OR HANDLING ISSUES COULD NOT BE RULED OUT BASED ON MANY DAILY OCCURRENCES OF ERROR 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR) AND ERROR 3104 (UNABLE TO PROCESS TEST, LIQUID CONTACT BROKEN DURING ASPIRATION FOR SAMPLE PIPETTOR AT SAMPLE CARRIER). THE ICT MODULE LOT/SERIAL NUMBER WAS NOT AVAILABLE TO VERIFY THE ICT MODULE WAS WITHIN ITS EXPIRATION DATE. THE ICT MODULE INSTALLATION DATE WAS NOT PROVIDED AND IT COULD NOT BE DETERMINED FROM THE C800412 LOGS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT C8000 ANALYZER GENERATED LOW POTASSIUM RESULTS OF APPROXIMATELY 2 MEQ/L ON A COUPLE OF PATIENTS. THE PATIENTS WERE REPEATED AND NORMAL RESULTS OF APPROXIMATELY 4 MEQ/L WERE GENERATED. NO SPECIFIC PATIENT DATA WAS PROVIDED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150965 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE 9D28-03| ICT MODULE 9D28-03