BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2110719 · Received June 1, 2011

    Report

    Report Number
    1628664-2011-00250
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO RESULTS OF INVESTIGATION BELOW. TO INVESTIGATE THE CUSTOMER'S ISSUE, THE COMPLAINT TEXT, THE SYSTEM LOGS, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING WERE REVIEWED. THE RESULT LOG CONFIRMS THE INITIAL AND REPEATED POTASSIUM RESULTS GENERATED ON (B)(6) 2011 FOR SAMPLE ID #'S (B)(6) (REPEAT) AND (B)(6) (INITIAL). THE INITIAL RESULT WAS FLAGGED >. FOURTEEN CLINICAL CHEMISTRY TESTS WERE ORDERED FOR THE SUSPECT SAMPLE AND NINE RESULTS WERE REPEATED INCLUDING THE SUSPECT POTASSIUM RESULT. FIVE OF THE REPEATED TESTS WERE INITIALLY FLAGGED LOW OR HIGH. THE PRESSURE MONITORING LOG DID NOT CONTAIN ANY DATA THAT WOULD HAVE BEEN BENEFICIAL IN DETERMINING IF THERE WERE ANY ABNORMALITIES WITH THE ASPIRATION AND DISPENSE FOR SID (B)(6). A POSSIBLE CAUSE FOR THE CUSTOMER'S ISSUE IS SAMPLE CONTAMINATION BECAUSE MULTIPLE RESULTS, NOT JUST POTASSIUM, WERE REPEATED AND THE MAJORITY OF THE REPEATED RESULTS WERE FLAGGED HIGH OR LOW FOR SID (B)(6). ADDITIONALLY, THE POTASSIUM RESULT OF >10.0 MMOL/L IS EXTREMELY HIGH. THE SERVICE HISTORY REVIEW OF ARCHITECT SERIAL # (B)(4) FOUND NO RECURRENCE OF ERRATIC AND/OR POTASSIUM RESULTS. A REVIEW OF QUALITY METRICS DID NOT IDENTIFY ANY ADVERSE TRENDS RELATED TO THE CUSTOMER'S ISSUE. PRODUCT LABELING IN THE ICT SAMPLE DILUENT PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL ARE SUFFICIENT WITH REGARD TO ICT MODULE USE, MAINTENANCE AND REPLACEMENT, CALIBRATION AND CONTROL REQUIREMENTS, IMPRECISION CLAIMS AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY COULD NOT BE IDENTIFIED. THE SYSTEM LOGS REVEALED THAT MULTIPLE RESULTS, NOT JUST POTASSIUM WERE REPEATED AND THE MAJORITY OF THE REPEATED RESULTS WERE FLAGGED HIGH OR LOW FOR SID (B)(6). THEREFORE, A POSSIBLE CAUSE FOR THE CUSTOMER'S ISSUE IS SAMPLE CONTAMINATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER GENERATED AN INITIAL POTASSIUM RESULT OF >10 MMOL/L. THE SAMPLE WAS REPEATED 2 TIMES AND BOTH RESULTS WERE 4.5 MMOL/L. THE RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR ARCHITECT ICT MODULE| ARCHITECT ICT MODULE