BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2150182 · Received July 6, 2011

    Report

    Report Number
    1628664-2011-00522
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4); HIGH TEST RESULTS. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, INSTRUMENT LOGS, INSTRUMENT SERVICE HISTORY, AND OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES. THE CUSTOMER'S ISSUE WAS RESOLVED BY CHANGING THE ICT MODULE. THE INSTRUMENT LOGS SHOWED MILLIVOLT (MV) FLUCTUATIONS BETWEEN PRE AND POST SAMPLES IREF READS DURING ICT TESTING, BUT THE FLUCTUATIONS DID NOT EXCEED THE LIMIT OF 10 MV VOLTAGE DRIFT LIMIT SO AN ERROR CODE WAS NOT GENERATED. IREF MV FLUCTUATIONS MAY BE CAUSED BY MISSING OR IMPROPERLY SEATED O-RINGS, LOOSE ICT MODULE ELECTRICAL CONNECTOR, OR THE ICT MODULE NOT CONNECTED CORRECTLY. SIMILAR INSTRUMENT LOGS HAVE BEEN FORWARDED TO R&D FOR FURTHER EVALUATION FOR AN ENHANCEMENT TO THE VOLTAGE DRIFT LIMIT TO BETTER DETECT FLUCTUATIONS BETWEEN PRE AND POST IREF READS. SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS IN THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS SEVERAL PROBABLE CAUSES FOR ERRATIC RESULTS, INCLUDING ICT PROBE DAMAGED OR NOT CONNECTED CORRECTLY, ICT MODULE CONTAMINATED, EXPIRED, MISSING O-RINGS OR NOT PERFORMING AS EXPECTED, 1 ML SYRINGES, ICT CHECK VALVES, AND LOOSE ICT MODULE ELECTRICAL CONNECTOR. CORRECTIVE ACTIONS INCLUDE REPLACING THE ICT PROBE, TIGHTENING THE ICT PROBE TO THE ICT MODULE, RESEATING OR REPLACING O-RINGS, BLEACHING THE ICT MODULE, RESEATING OR REPLACING 1 ML SYRINGES, REPLACING THE ICT MODULE, TIGHTENING CONNECTIONS FOR SYRINGES AND TUBING, REPLACING CHECK VALVES, AND RESEATING ICT MODULE ELECTRICAL CONNECTOR. A REVIEW OF INSTRUMENT SERVICE HISTORY, CUSTOMER COMPLAINTS AND QUALITY METRICS DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THIS ISSUE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED FALSELY ELEVATED RESULTS WERE GENERATED ON THE ARCHITECT C8000 ANALYZER. A PATIENT SPECIMEN GENERATED CHLORIDE RESULTS OF 103 AND 116 MMOL/L AND SODIUM RESULTS OF 136 AND 122 MMOL/L. THE ISSUE WAS RESOLVED BY REPLACING THE ICT MODULE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    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 64 YR ICT MODULE LIST # 9D28-03 (B)(4)| ICT MODULE LIST # 9D28-03 (B)(4)