BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3759667 · Received April 18, 2014

    Report

    Report Number
    1628664-2014-00068
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE SAMPLE PROBE, CHECKED THE CUVETTE WASHER, CHECKED THE PUMPS, AND RAN A CREATININE REPRODUCIBILITY TEST ALONG WITH INTERNAL AND EXTERNAL CONTROLS. THE TWO DISCREPANT MULTIGENT ENZYMATIC CREATININE RESULTS WERE RUN AGAIN AFTER THE PROBE WAS REPLACED. A PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. FURTHER REVIEW OF THE COMPLAINT TEXT INDICATES THE INSTRUMENT LOGS WERE REVIEWED FOR C802861 AND SEVERAL ERROR CODE 0550 ERRORS (CUVETTE WASHING NOT COMPLETED, HARDWARE FAILURE OR USER PRESSED STOP. PROMPTLY PERFORM THE WASH CUVETTES PROCEDURE) WERE FOUND IN THE LOGS REVIEWED. THE CUSTOMER WAS EDUCATED ABOUT ERROR CODE 0550 AND INSTRUCTED ON HOW TO PERFORM CUVETTE WASH. A REVIEW OF THE INSTRUMENT SERVICE HISTORY WAS PERFORMED, AND NO ADDITIONAL SERVICE OR COMPLAINTS SIMILAR TO THIS ISSUE WERE FOUND. NO ADVERSE TRENDS FOR TICKETS WITH REPLACEMENTS OF THE SAMPLE PROBE WERE IDENTIFIED. THE CUSTOMER WAS REFERRED TO THE ARCHITECT SYSTEM OPERATIONS MANUAL WHICH PROVIDES INFORMATION FOR TROUBLESHOOTING ERRATIC RESULTS INCLUDING REPLACING THE PROBE, AND INFORMATION FOR ERROR CODE 0550. BASED ON THE RESULTS OF THE INVESTIGATION, NO DEFICIENCY OF THE SAMPLE PROBE OR ARCHITECT C8000 INSTRUMENT WAS IDENTIFIED. AS THE CUSTOMER WAS ADVISED ABOUT ERROR CODE 0550, CUVETTE WASHING, AND REPLACED THE SAMPLE PROBE, NO MALFUNCTION OF THE SAMPLE PROBE OR THE ARCHITECT C8000 INSTRUMENT WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED DISCREPANT PATIENT RESULTS FOR THE MULTIGENT ENZYMATIC CREATININE ASSAY. A RESULT OF 280 UMOL/L (3.17 MG/DL) WAS REPEATED AT 78 UMOL/L (0.9 MG/DL) AND A RESULT OF 45.48 UMOL/L (0.514 MG/DL) WAS REPEATED AT 370 UMOL/L (4.2 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE SAMPLE PROBE WAS REPLACED IN ORDER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237164 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 MLTIGENT ENZYMATIC CREATININE| MLTIGENT ENZYMATIC CREATININE