BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 1935880 · Received December 22, 2010

    Report

    Report Number
    1628664-2010-00502
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CALIBRATION FAILURES AND CONTROLS OUT OF RANGE. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, INSTRUMENT LOGS, INSTRUMENT SERVICE HISTORY AND OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES. THE INSTRUMENT LOGS SHOWED CALIBRATION ERROR CODES SUCH AS 1405 (CALIBRATION OUT OF ORDER, CALIBRATION FAILED) AND ERROR CODE 1156 (CALIBRATION FAILURES). THE SLOPE WAS OUTSIDE OF DEFINED RANGE PRIOR TO THE HIGH SODIUM PATIENT RESULT BEING GENERATED. THE LOGS ALSO SHOWED SODIUM QUALITY CONTROLS OUT OF RANGE PRIOR TO THE HIGH SODIUM PATIENT RESULT. THE PATIENT RESULT ALSO HAD A CNTL H FLAG. THE TROUBLE SHOOTING SECTION OF THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS SEVERAL PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR QUALITY CONTROLS OUT OF RANGE AND FOR SUCH ERROR CODES INCLUDING RECALIBRATION OF THE ASSAY. THE DESCRIPTION OF THE PATIENT RESULTS FLAGS IN THE OPERATIONS MANUAL DESCRIBES THE CNTL FLAG FOR PATIENT RESULTS (AFTER QUALITY CONTROLS FAIL THE CONFIGURED (B)(4) RULES, THE FLAG WILL APPEAR ON PATIENT RESULTS UNTIL THE FAILED QUALITY CONTROL RESULTS ARE RERUN AND ARE WITHIN THE ACCEPTABLE LIMITS. THE ISSUE WAS RESOLVED BY RECALIBRATING THE ASSAY SUCCESSFULLY. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED HIGHER THAN EXPECTED PATIENT RESULTS FOR THE SODIUM (180 MMOL/L). THE RESULTS WERE WITHIN THE NORMAL RANGE WHEN REPEATED AFTER RECALIBRATION. THE CUSTOMER BELIEVES THE ISSUE TO BE DUE TO CALIBRATION INSTABILITY ALTHOUGH THE INITIAL CALIBRATION DID NOT FAIL. THE INITIAL HIGH RESULTS WERE NOT REPORTED OUT AND THEREFORE, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JGS ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 AERO C8K ICT MODULE FOR SODIUM| AERO C8K ICT MODULE FOR SODIUM